BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGIONAL ANALGESIA INFUSOR W/PATIENT CONTROL MODULE 5.0-7.0

    MDR report key: 1994118 · Received February 16, 2011

    Report

    Report Number
    6000001-2011-01103
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K051253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: NO SAMPLE WAS AVAILABLE, SO THE ROOT CAUSE WAS UNDETERMINED. 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. A BATCH REVIEW HAS BEEN PERFORMED AND THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF "OVER-INFUSION" COULD NOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) REGIONAL ANALGESIA INFUSOR W/ PATIENT CONTROL MODULE HAD OVER-INFUSED DURING PATIENT USE. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH 100ML OF 4% IFOSFAMIDE IN SODIUM CHLORIDE AND 52ML OF UOMITEXAN AND WAS EXPECTED TO DELIVER IN 22 HOURS BUT INSTEAD WAS INFUSING FASTER THAN ANTICIPATED (UNKNOWN RATE). THE PATIENT'S ACCESS SITE WAS A CENTRAL IMPLANTABLE PORT. THE INFUSOR WAS SET TO 7 ML/H AND THE 5ML BOLUS WAS NOT USED. THE CUSTOMER NOTED THE DEVICE WAS INFUSING FAST AND TRIED TO PREVENT AN OVER-DELIVERY BY ADDING AN ADDITIONAL 130ML OF SODIUM CHLORIDE TO THE DEVICE IN THE MIDDLE OF THERAPY; THIS ALLOWED THE INFUSOR TO DELIVER THE REMAINING DRUG AND NORMAL SALINE ALMOST UNTIL THE SCHEDULED STOP TIME. THE REPORTER INFORMED THAT THE PHYSICIAN CONFIRMED THAT THERE WERE NO MEDICAL CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REGIONAL ANALGESIA INFUSOR W/PATIENT CONTROL MODULE 5.0-7.0 PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10E065

    Patients

    Seq Age Sex Outcome Treatment
    1 UOMITEXAN| IFOSFAMIDE| SODIUM CHLORIDE