BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2103433 · Received May 26, 2011

    Report

    Report Number
    6000001-2011-04653
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A LEAK WAS NOT CONFIRMED. UPON SAMPLE RECEIPT, THE DEVICE CONTAINED APPROXIMATELY 50 ML OF FLUID IN THE BLADDER. A FILLING SYRINGE CONTAINING APPROXIMATELY 60 ML OF SOLUTION WAS ALSO RECEIVED CONNECTED TO THE INFUSOR'S FILL PORT. NO EVIDENCE OF LEAK OR BACKFLOW WAS NOTED AT THE FILL PORT WHEN THE SYRINGE WAS REMOVED. HOWEVER, THE FILLPORT WAS NOTED TO BE CHIPPED, AND THE TIP OF THE SYRINGE TO BE SLIGHTLY BENT. THE SAMPLE WAS SUBSEQUENTLY FILLED TO ITS MAXIMUM VOLUME. THERE WAS STILL NO EVIDENCE OF LEAK DETECTED ANYWHERE ON THE DEVICE DURING FILLING AND PRIMING. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD 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.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEVIED A REPORT THAT ONE (1) BAXTER INFUSOR SV2 DEVICE (CODE (B)(4) LOT 10C110) SHOWED A BACKFLOW DURING THE FILLING STEP. ACCORDING TO THE REPORTER, DURING THE FILLING OF THE SECOND SYRINGE OF SOLUTION A BACKFLOW WAS OBSERVED AT THE LEVEL OF THE FILLING PORT. THIS OCCURRED PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10C110

    Patients

    Seq Age Sex Outcome Treatment
    1