BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2863562 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06818
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: 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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. THE REPORTED CONDITION WAS CONFIRMED DURING EVALUATION. MICROSCOPIC EVALUATION WAS PERFORMED AND DAMAGE WAS FOUND ON THE BLADDER OF THE DEVICE. THE ROOT CAUSE WAS DETERMINED TO BE A MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    BAXTER FRANCE RECEIVED A REPORT THAT AN INFUSOR HAD A RESERVOIR RUPTURE DURING FILLING. THE DEVICE WAS BEING FILLED WITH SALINE. 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 AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12E028

    Patients

    Seq Age Sex Outcome Treatment
    1