BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 462885 · Received May 23, 2003

    Report

    Report Number
    MW1028537
    Event Type
    Malfunction
    Date Received
    May 23, 2003
    Report Date
    May 23, 2003
    Manufacturer
    ALARIS MEDICAL SYSTEMS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM THE MFR 08/05/03: LABORATORY ANALYSIS WAS DEEMED NECESSARY TO DETERMINE FAILURE MODES FOR THE REPORTED EVENT. THE USER'S CONCERNS REGARDING THERAPEUTIC DOSAGE DELIVERY AND CAREGIVER EXPOSURE APPEAR TO BE UNWARRANTED, GIVEN THAT ONLY SOLVENT CAPABLE OF DISSOLVING THE ABSORBED COMPOUND WAS CHLOROFORM. ADDITIONALLY, GIVEN THE PRESENCE OF NO METHYLENE BLUE ON MECHANISM SEAL "4015156" AS WELL AS NO RESIDUAL CARRIER AGENTS, IT SEEMS UNLIKELY THAT COMPOUNDS THAT ARE CLEAR AND POSSESS MOLECULAR WEIGHT OF APPROX 320 OR HIGHER PRESENT A HAZARD TO CAREGIVERS. GIVEN THAT MFR HAS NOT IDENTIFIED A MECHANISM OF ACTION AND THE POSSIBILITY EXISTS THAT OTHER LOW-MOLECULAR WEIGHT COMPOUNDS WILL BE DEVELOPED, ALARIS CONSIDERS IT IMPORTANT TO CONTINUE TESTING; THE NATURE OF THESE TESTS HAS NOT YET BEEN DEFINED.

    Description of Event or Problem · 1

    A PT WAS BEING TREATED WITH SU 5416 VIA ALARIS MEDLEY INFUSION PUMP. FOLLOWING INFUSION OF SU 5416, IT WAS NOTED THAT THE DRUG COLOR -BRIGHT YELLOW- HAD BEEN ABSORBED BY THE PLASTIC MEMBRANE INTERNAL TO THE PERISTALTIC PUMPING MECHANISM OF THE PUMP CHAMBER. THIS HAS BEEN DETECTED IN 4 SEPARATE PUMPS. THERE IS NO EVIDENCE OF DEFECTIVE TUBING. IT APPEARS THAT THERE IS DIFFUSION THROUGH THE SILICONE TUBING THAT IS INSERTED INTO THE PUMP CHAMBER. OF NOTE, THIS PT HAS BEEN RECEIVING SU 5416 SINCE MARCH 2001. IN APRIL, 2003 CHANGED FROM THE 3M INFUSION PUMP TO THE ALARIS MEDLEY INFUSION PUMP. THIS PROBLEM WAS NEVER REPORTED WITH THE 3M INFUSION PUMP. THE 4 ALARIS PUMPS HAVE BEEN REMOVED FROM SERVICE WHILE THIS PROBLEM IS UNDER INVESTIGATION. DATES OF SERVICE WITH THE ALARIS PUMP ARE APRIL AND MAY 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS MEDLEY INFUSION PUMP MODULE FRN ALARIS MEDICAL SYSTEMS 8100AX04EE *
    2 ALARIS MEDLEY INFUSION PUMP MODULE FRN ALARIS MEDICAL SYSTEMS 8100AX04EE *
    3 ALARIS MEDLEY INFUSION PUMP MODULE FRN ALARIS MEDICAL SYSTEMS 8100AX04EE *
    4 ALARIS MEDLEY INFUSION PUMP MODULE FRN ALARIS MEDICAL SYSTEMS 8100AX04EE *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR