BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2103320 · Received May 26, 2011

    Report

    Report Number
    6000001-2011-04641
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K884505
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING APPROXIMATELY 5 ML OF SOLUTION IN THE HOUSING. THE REPORTED CONDITION OF A LEAK INSIDE THE HOUSING WAS CONFIRMED. A LEAK TEST WAS PERFORMED BY FILLING THE RESERVOIR WITH GREEN WATER. IMMEDIATELY DURING FILL, THE GREEN WATER WENT DIRECTLY INTO THE HOUSING, NOT INTO THE RESERVOIR. THE ROOT CAUSE WAS DETERMINED TO BE HALF-BROKEN COILED TUBING. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    BAXTER SWEDEN RECEIVED A REPORT THAT ONE (1) INFUSOR DEVICE LEAKED DURING FILLING. THE REPORT STATES THAT WHEN FILLING THE DEVICE, SOLUTION DID NOT FILL PROPERLY INTO THE RESERVOIR, JUST INSIDE THE HOUSING. IT IS UNKNOWN WITH WHAT THE DEVICE WAS BEING FILLED. NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10M085

    Patients

    Seq Age Sex Outcome Treatment
    1