BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD ADMINISTRATION SET WITH ANTI SIPHON VALVE

    MDR report key: 1432335 · Received August 4, 2009

    Report

    Report Number
    MW5012257
    Event Type
    Malfunction
    Date Received
    August 4, 2009
    Date of Event
    August 3, 2009
    Report Date
    August 4, 2009
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THIS REPORT INVOLVES THE CAESAREA MEDICAL ELECTRONICS LTD. BODYGUARD ADMINISTRATION SET WITH ANTI SIPHON VALVE, MALE LUER LOCK - THIS IS A TUBING SET THAT THE BODYGUARD AMBULATORY PUMP USES TO DELIVER MEDICATIONS. ON THIS PARTICULAR TUBING SET, THE PUMP KEY -THE BLACK PIECE OF PLASTIC THAT FITS INTO THE BODYGUARD PUMP- IS BACKWARDS. THE PUMP KEY IS CRUCIAL IN OPERATING THE BODYGUARD PUMP AND THERE IS ONLY ONE WAY TO INSERT IT WHICH ENSURES THAT THE TUBING IS CORRECTLY IN PLACE. WITH THE PUMP KEY BACKWARDS, THE PUMP KEY CANNOT BE CORRECTLY PLACED IN THE BODYGUARD PUMP, RENDERING THE BODYGUARD PUMP INEFFECTIVE TO DELIVER MEDICATIONS. WE HAVE NOT BEEN ABLE TO NARROW DOWN A LOT NUMBER BECAUSE IT APPEARS THAT MULTIPLE LOT NUMBERS HAVE HAD THIS SAME PROBLEM. TO COMPLICATE MATTERS, THERE ARE MULTIPLE LOT NUMBERS IN EACH BOX SENT TO US. ONE OF OUR SUSPECTED LOT NUMBERS IN QUESTION IS LOT NUMBER 10639-09/3. DATES OF USE: 48 HOURS. DIAGNOSIS OR REASON FOR USE: TUBING FOR PUMP TO DELIVER HYDRATION FLUIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BODYGUARD ADMINISTRATION SET WITH ANTI SIPHON VALVE BODYGUARD TUBING -WITHOUT FILTER- FPA CME AMERICA, LLC 120-160XPS 10639-09/3

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other