Docstoc

Disposable medication cassette reservoirs for Smiths CADD-Legacy

Document Sample
Disposable medication cassette reservoirs for Smiths CADD-Legacy Powered By Docstoc
					                   HAZARD NOTICE
                     By arrangement with the Scottish Executive Health Department

                                                                                                       HAZ(SC)07/11
DISPOSABLE MEDICATION CASSETTE RESERVOIRS FOR SMITHS                                                    29 JUN 2007
CADD-LEGACY® PCA AMBULATORY INFUSION PUMPS:                                                            Medical Devices
PRODUCT RECALL ON CERTAIN BATCHES                                                                     Page 1 of 3 Pages

SUMMARY

The pH of some medications may increase when used with certain batches of disposable medication
cassette reservoirs for use with the Smiths Medical CADD-Legacy® PCA ambulatory infusion pumps.
The manufacturer has implemented a product recall on implicated batches.

BACKGROUND

1. Smiths Medical manufactures a range of infusion pumps including the CADD-Legacy® PCA
   ambulatory infusion pump model number 6300 (see Figure 1, page 3). These pumps use a
   disposable medication cassette reservoir (see Figure 2, page 3). Smiths Medical has advised that in
   May 2006 there was a change of supplier for the PVC material used to produce the bag contained
   within the disposable medication cassette reservoir. However, the new supplier’s material
   formulation included calcium carbonate.

2. Smith’s Medical subsequently received adverse incident reports associated with batches produced
   using the new material formulation. Reports include pH increases from pH 3 to 6.9 and yellow
   discolouration when filled with morphine hydrochloride over a period of seven days. There have
   also been reports in the USA of catheter occlusions during the delivery of Flolan® where the
   medication cassette reservoir was part of the infusion system. Identification criteria for implicated
   cassettes are given in Table 1:
     Products                                                  Size       Reorder code                   Batch numbers
     Medication cassette reservoirs for CADD-                 50ml         21-7001-24                   102X16 to 226X16
     Legacy® PCA ambulatory infusion pumps                    100ml        21-7002-24                   081X16 to 229X16
                                                     Table 1

3. Smiths Medical conducted independent tests which confirmed that in the implicated cassettes:
   • there is an upward pH change of up to 4 units after 24 hours for a non-buffered weak acid
      solution from pH 3.70 to pH 7.80,
   • dopamine hydrochloride solution showed a slight yellowing with pH rising from 3.77 to 6.46
      after 48 hours,
   • an admixture of fentanyl citrate and bupivicaine hydrochloride showed a degradation in drug
      concentration of 19.7% and 17.2% respectively at 120 hours and pH increase from 4.73 to 6.66
      after 24 hours.

Suggested Distribution        Accident & Emergency            Anaesthetics                           Care Home Services
District Nursing              General Medical Practitioners   Health & Safety                        Health Centres
Hospices                      Intensive Therapy Units         Medical                                Medical Physics
Nursing                       Oncology                        Operating Departments                  Pharmacy
Practice Nurses               Risk Management                 Stores                                 Supplies/Procurement
Wards

                                 SCOTTISH HEALTHCARE SUPPLIES
                                    Gyle Square Edinburgh EH12 9EB
                            A Division of the National Service Scotland for NHSScotland
CONTACT EMAIL: iric@shs.csa.scot.nhs.uk                                                                     FAX: 0131 314 0722
WEBSITE: http://www.nhsscotland.com/shs/hazards_safety/adverse_p.html      N:\WORD\HAZ\IRIC PUBLICATIONS\FINAL HAZ\PUBLIC HAZ\PHAZ0711.DOC
                   HAZARD NOTICE
                     By arrangement with the Scottish Executive Health Department

                                                                                                       HAZ(SC)07/11
DISPOSABLE MEDICATION CASSETTE RESERVOIRS FOR SMITHS                                                    29 JUN 2007
CADD-LEGACY® PCA AMBULATORY INFUSION PUMPS:                                                            Medical Devices
PRODUCT RECALL ON CERTAIN BATCHES                                                                     Page 2 of 3 Pages


4. In January 2007, production of the cassettes reverted to the original material formulation and Smiths
   Medical no longer supply cassettes manufactured with the material containing calcium carbonate.

5. Yellow medication cassette reservoirs with clamp and female luer, reorder code 21-7100, are not
   implicated in this notice and have not been recalled.

ACTION

6. This notice should be brought to the attention of all appropriate managers, staff and users.

7. All implicated Smiths Medical medication cassette reservoirs for CADD-Legacy® PCA ambulatory
   infusion pumps, reorder codes 21-7001-24 and 21-7002-24 (see Table 1) should be identified,
   removed from use and placed in quarantine.

8. If there are inadequate supplies of cassettes from non-implicated batches while replacements are
   awaited, consideration should be given to using an alternative infusion system. Arrangements
   should be made to ensure infusion therapies continue uninterrupted.

9. Smiths Medical should be contacted (see Enquiries) to arrange for free of charge replacements for
   implicated cassettes. If Smiths Medical do not require the return of implicated cassettes, they
   should be safely disposed of when replacements are received.

10. Adverse incidents involving disposable medication cassette reservoirs for use with the Smiths
    Medical CADD-Legacy® PCA ambulatory infusion pumps should be reported to Smiths Medical
    and Scottish Healthcare Supplies.

ENQUIRIES

Enquiries to the manufacturer should be addressed to:

        Jon Charters
        Quality Assurance Manager
        Smiths Medical International Ltd
        Colonial Way
        Watford
        WD24 4LG
        Tel:    01923 246 434
        E-mail: jon.charters@smiths-medical.com



                                 SCOTTISH HEALTHCARE SUPPLIES
                                    Gyle Square Edinburgh EH12 9EB
                            A Division of the National Service Scotland for NHSScotland
CONTACT EMAIL: iric@shs.csa.scot.nhs.uk                                                                     FAX: 0131 314 0722
WEBSITE: http://www.nhsscotland.com/shs/hazards_safety/adverse_p.html      N:\WORD\HAZ\IRIC PUBLICATIONS\FINAL HAZ\PUBLIC HAZ\PHAZ0711.DOC
                   HAZARD NOTICE
                     By arrangement with the Scottish Executive Health Department

                                                                                                       HAZ(SC)07/11
DISPOSABLE MEDICATION CASSETTE RESERVOIRS FOR SMITHS                                                    29 JUN 2007
CADD-LEGACY® PCA AMBULATORY INFUSION PUMPS:                                                            Medical Devices
PRODUCT RECALL ON CERTAIN BATCHES                                                                     Page 3 of 3 Pages




                                                                                  Pump




                                                                                    Disposable medication
                                                                                    cassette reservoir




                                           Figure 1
              Smiths Medical CADD-Legacy® PCA ambulatory infusion pump, model 6300




                                                 Figure 2
                                   Disposable medication cassette reservoir




                                 SCOTTISH HEALTHCARE SUPPLIES
                                    Gyle Square Edinburgh EH12 9EB
                            A Division of the National Service Scotland for NHSScotland
CONTACT EMAIL: iric@shs.csa.scot.nhs.uk                                                                     FAX: 0131 314 0722
WEBSITE: http://www.nhsscotland.com/shs/hazards_safety/adverse_p.html      N:\WORD\HAZ\IRIC PUBLICATIONS\FINAL HAZ\PUBLIC HAZ\PHAZ0711.DOC

				
DOCUMENT INFO