BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2091555 · Received May 17, 2011

    Report

    Report Number
    6000001-2011-04123
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING APPROXIMATELY 40 ML OF DRUG SOLUTION IN THE RESERVOIR. THE REPORTED CONDITION OF NO FLOW WAS CONFIRMED. UPON SAMPLE RECEIPT, VISUAL EXAMINATION OF THE UNIT NOTED EXCESSIVE DRUG PRECIPITATE THROUGHOUT THE SOLUTION OF THE RESERVOIR. FLOW WAS NOT READILY OBSERVED AT THE LUER DESPITE SEVERAL ATTEMPTS OF FORCED PRIME. WHEN THE TUBING WAS CUT TO DRAIN THE DRUG SOLUTION, VERY SLOW DRIPS OF DRUG SOLUTION WERE NOTED COMING OUT OF THE CUT TUBING INSTEAD OF THE NORMAL, FAST-FLOWING SOLUTION. MICROSCOPIC EXAMINATION OF THE FLOW RESTRICTOR FOUND EVIDENCE OF DRUG PRECIPITATE BLOCKING THE FLUID EXIT AT THE END OF THE GLASS CAPILLARY (LOCATED WITHIN THE FLOW RESTRICTOR HOUSING). THE ROOT CAUSE WAS DETERMINED TO BE DRUG CRYSTALLIZATION AT THE END OF THE GLASS CAPILLARY. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A COMPLAINT INVOLVING AN INFUSOR SINGLEDAY 2ML/HR 12PK DEVICE. ACCORDING TO THE REPORT, A NO-FLOW WAS DETECTED FROM THE INFUSOR. THIS WAS NOTICED BY THE PATIENT PRIOR TO CONNECTION. THE CAP WAS REMOVED AND NO SOLUTION CAME OUT. IT IS UNKNOWN WITH WHAT THE DEVICE WAS FILLED. THIS REPORT WILL REFERENCE 2 OF 2 FROM THIS FACILITY, AS 2 DEVICES WERE IMPLICATED. NO REPORT OF PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10K043

    Patients

    Seq Age Sex Outcome Treatment
    1