BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR SV 0.5 ML/H

    MDR report key: 1800024 · Received August 16, 2010

    Report

    Report Number
    6000001-2010-02562
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL EXAMINATION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF A LEAK AT THE CONNECTION OF THE BLUE WINGED CAP AND THE LUER BODY, HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. BATCH REVIEW DETERMINED THAT NO NONCONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT DURING MANUFACTURING. TREND REVIEW DETERMINED THAT BAXTER HAS RECEIVED SIMILAR REPORTS. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS AND GI BLEED IN AN APPROXIMATELY (B)(6) FEMALE HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON (B)(6) 2010, THE PATIENT WENT TO THE ER AND WAS DIAGNOSED WITH A GI BLEED. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED DUE TO THE GI BLEED. THE CAUSE OF THE GI BLEED WAS UNKNOWN. THE PATIENT WAS RECOVERING AND WAS STILL HOSPITALIZED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A FOLFUSOR SV 0.5 DEVICE WAS LEAKING BEFORE PATIENT USE. THE DEVICE WAS FILLED WITH 572 MILLIGRAMS/84 MILLILITERS DESFERRIOXAMINE WHEN THE LEAK WAS OBSERVED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLFUSOR SV 0.5 ML/H PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09A014

    Patients

    Seq Age Sex Outcome Treatment
    1