BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 2091851 · Received May 17, 2011

    Report

    Report Number
    6000001-2011-04151
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: 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 AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A LEAK WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. UPON SAMPLE RECEIPT, NO EVIDENCE OF LEAK WAS NOTED ANYWHERE ON THE ENTIRE DEVICE. THE SAMPLE WAS SUBSEQUENTLY FILLED TO ITS MAXIMUM VOLUME. THERE WAS STILL NO EVIDENCE OF LEAK DETECTED ANYWHERE ON THE DEVICE DURING FILLING AND PRIMING. THEREAFTER, THE DEVICE WAS MONITORED FOR 24 HOURS. AFTER 24 HOURS, THERE WAS STILL NO EVIDENCE OF LEAK ANYWHERE ON THE ENTIRE DEVICE. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. 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.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT ONE (1) FOLFUSOR LV 10 ML/H DEVICE REPORTEDLY LEAKED BEFORE PRIMING. THE DEVICE WAS FILLED WITH NACL. THE SAMPLE HAS BEEN EMPTIED BY THE CUSTOMER. ONE UNIT AFFECTED / SAMPLE AVAILABLE. THE REPORTED COMPLAINT TOOK PLACE BEFORE PATIENT CONNECTION, NO PATIENT INVOLVEMENT. NO MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11A012

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE