BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2922753 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01400
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A RUPTURED RESERVOIR WAS CONFIRMED. VISUAL EXAMINATION OF THE UNIT DETERMINED THAT THE BLADDER RUPTURED IN A NON-FOOTED POSITION. THE ROOT CAUSE WAS DETERMINED TO BE A OPERATIONAL ERROR. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. THE SAMPLE BECAME AVAILABLE AFTER SUBMISSION OF INITIAL MEDICAL DEVICE REPORT (MDR).

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT OF AN INTERMATE THAT HAD A BROKEN RESERVOIR DURING FILLING. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. 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
    27526 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12B062

    Patients

    Seq Age Sex Outcome Treatment
    1