BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2100290 · Received May 24, 2011

    Report

    Report Number
    6000001-2011-04434
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. A CONNECTOR WAS ALSO RECEIVED WITH THE UNIT. VISUAL EXAMINATION OF THE INFUSOR FOUND NO SIGNS OF DEFECT OR ABNORMALITY ON THE COMPONENTS. HOWEVER, A CRACK LINE WAS FOUND ON THE CONNECTOR. A LEAK TEST WAS SUBSEQUENTLY PERFORMED BY CONNECTING THE CRACKED CONNECTOR TO THE INFUSOR'S LUER, THEN FILLING THE INFUSOR'S RESERVOIR WITH GREEN WATER. APPROXIMATELY TEN MINUTES AFTER FILL, SMALL TRACES OF GREEN WATER WERE NOTED COMING OUT OF THE CRACK LINE ON THE CONNECTOR. NO OTHER LOCATION OF LEAKAGE WAS NOTED DURING THE LEAK TEST. BASED ON THE FINDINGS, THE CAUSE OF LEAKAGE WAS DUE TO A CRACKED CONNECTOR. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT ON AN UNDEFINED OCCURRENCE DATE 4 UNITS OF INFUSOR SINGLEDAY LEAKED AT THE LEVEL OF THE DISTAL LUER DURING INFUSION. ACCORDING TO THE REPORTER, THE DEVICE SHOWED LEAKAGE 3 HOURS AFTER THE INFUSION STARTED. REPORTEDLY, THE PRODUCT INFUSED WAS DESFERAL (IRON). THIS COMPLAINT WILL ADDRESS REPORT 3 OF 4, AS THE FACILITY REPORTED 4 UNITS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10J022

    Patients

    Seq Age Sex Outcome Treatment
    1 DESFERAL| EPI-CRANIAN G25 20 MM (B)(4)| DESFERAL