BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U0605 6464602 PCA II PUMP

    MDR report key: 1212984 · Received October 29, 2008

    Report

    Report Number
    6000001-2007-98832
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    July 6, 2007
    Report Date
    July 7, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION, SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 16, 2007. DEVICE HAS BEEN REQUESTED FOR EVALUATION. IF THE DEVICE IS RECEIVED AND AN EVALUATION PERFORMED, A FOLLOW-UP REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BATTERY ACID WAS FOUND ON THE INSIDE OF THIS PCAII PUMP. PUMP HAD BEEN SENT TO THE BIOMED GROUP AT THE FACILITY FROM THE FLOOR WITH A REPORT INDICATING THAT THE PUMP WAS NOT FUNCTIONING PROPERLY. TECHNICIAN FOUND BATTERY ACID INSIDE THE PUMP DURING TESTING. TECHNICIAN REPORTED A COMPONENT WAS DAMAGED BY THE BATTERY ACID. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE PROBLEM OCCURRED DURING A PATIENT INFUSION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED ON THIS REPORT. NO PATIENT INVOLVEMENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U0605 6464602 PCA II PUMP 80FRN FRN BAXTER HEALTHCARE CORPORATION, SINGAPORE N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1