BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2924250 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01575
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY RELEVANT, ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    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 FOOTED POSITION. THE RESERVOIR WAS ALSO MICROSCOPICALLY EXAMINED FOR ANY ABNORMALITIES THAT MAY HAVE POTENTIALLY CONTRIBUTED TO THE RUPTURE. HOWEVER, THE ROOT CAUSE OF THE REPORTED CONDITION WAS NOT DETERMINED. 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 PRODUCT SURVEILLANCE RECEIVED A REPORT FROM A CUSTOMER INDICATING A RUPTURE WAS OBSERVED ON AN INTERMATE DEVICE. ACCORDING TO THE REPORT, AFTER A PATIENT INFUSION, THE INTERMATE WAS DROPPED AND THE BLADDER RUPTURED AND LEAKED INTO THE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT, INJURY, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30372 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12K086

    Patients

    Seq Age Sex Outcome Treatment
    1