BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2933100 · Received January 29, 2013

    Report

    Report Number
    1416980-2013-02135
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE CONDITION OF A RUPTURED RESERVOIR WAS OBSERVED AND CONFIRMED BY BAXTER PERSONNEL. VISUAL EXAMINATION OF THE UNIT DETERMINED THAT THE BLADDER WAS RUPTURED IN A FOOTED POSITION. MICROSCOPIC EVALUATION REVEALED MARKINGS ON THE INTERIOR SURFACE OF THE BLADDER NEAR THE RUPTURE LINE, WHICH INDICATES INTERNAL DAMAGE, AND THIS INTERNAL DAMAGE CONTRIBUTED TO THE BLADDER RUPTURE. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. ADDITIONAL INFORMATION: THIS PRODUCT IS NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER. THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION.

    Description of Event or Problem · 1

    DURING EVALUATION BY BAXTER PERSONNEL, AN INFUSOR WAS FOUND TO HAVE A RUPTURED RESERVOIR. THIS INFUSOR WAS ATTACHED TO A PATIENT CONTROL MODULE (PCM), WHICH HAD BEEN SENT IN BY THE CUSTOMER TO BE EVALUATED FOR A SEPARATE ISSUE. THE RUPTURED CONDITION WAS FOUND DURING EVALUATION OF THE PCM AND WAS NOT REPORTED BY THE CUSTOMER; THEREFORE, ANY PATIENT INVOLVEMENT WITH THIS EVENT IS UNKNOWN. HOWEVER, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION WAS REPORTED IN RELATION TO THE INFUSOR OR PCM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38671 INFUSOR PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12C054

    Patients

    Seq Age Sex Outcome Treatment
    1