BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2911100 · Received January 11, 2013

    Report

    Report Number
    1416980-2013-00910
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K062457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A RUPTURE WAS NOT CONFIRMED. AFTER FURTHER INVESTIGATION, A LEAK WAS CONFIRMED TO BE THE ROOT OF THE REPORTED CONDITION. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. A FUNCTIONAL LEAK TEST REVEALED LEAKAGE AT THE VOLUME INDICATOR AND PORT. THE ROOT CAUSE WAS DETERMINED TO BE A MANUFACTURING DEFECT. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. 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

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR HAD A RESERVOIR RUPTURE BEFORE USE. THE DEVICE WAS FILLED WITH A SOLUTION OF DESFERAL. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17221 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12H059

    Patients

    Seq Age Sex Outcome Treatment
    1