BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE MULTIRATE INFUSOR SV1,2,312 PACK

    MDR report key: 1761267 · Received July 19, 2010

    Report

    Report Number
    6000001-2010-01755
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K051253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE CUSTOMER, THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF A RUPTURED RESERVOIR CANNOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS FILLED WITH A 100 ML SOLUTION OF MORPHINE CHLORINE HYDRATE (50MG) AND A DILUENT.A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.THE ROOT CAUSE FOR RUPTURED RESERVOIRS IS CURRENTLY BEING INVESTIGATED UNDER CAPA (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF A MULTIRATE INFUSOR DEVICE RUPTURED TWO MINUTES AFTER FILLING. THE DEVICE WAS FILLED WITH 100ML OF A STUPEFACIENT AT THE TIME OF THE RUPTURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY AS THIS EVENT DID NOT OCCUR DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A STONE REMOVAL PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS INSERTED INTO THE BILE DUCT AND THE SIDE CAR WAS FOUND TO BE TORN AND COULD NOT BE BACK-LOADED ALONG THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE MULTIRATE INFUSOR SV1,2,312 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09K037

    Patients

    Seq Age Sex Outcome Treatment
    1