BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3033618 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08295
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING NO FLUID IN THE RESERVOIR. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGN OF PHYSICAL ABNORMALITY. AN ACCURACY FLOW TEST WAS PERFORMED ON THE SAMPLE FOR 19.2 HOURS. THE INFUSOR PRODUCED FUNCTIONAL RESULTS WITHIN THE SPECIFICATION RANGE; THE DEVICE PERFORMED AS EXPECTED. THE REPORTED CONDITION OF AN OVERINFUSION WAS NOT CONFIRMED. NO ROOT CAUSE WAS IDENTIFIED, AS NO EVIDENCE OF PRODUCT MALFUNCTION WAS OBSERVED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT OF A BASAL/BOLUS INFUSOR THAT OVERINFUSED DURING PATIENT THERAPY. THE EXPECTED FLOW RATE OF THE DEVICE WAS 72ML/36HRS, HOWEVER, THE ACTUAL INFUSION TIME WAS 72ML/26HRS. THE PATIENT CONTROL MODULE (PCM) WAS ATTACHED AND PRESSED 2 TIMES DURING THERAPY. THE HEAD HEIGHT OF THE RESTRICTOR WAS ABOVE THE RESERVOIR. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136221 INFUSOR PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE| OXIFAST