BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR LV5, 12 PK

    MDR report key: 1982878 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00785
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: 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. 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). DEVICE EVALUATION: ONE FILLED UNIT WAS RECEIVED FOR EVALUATION BY BAXTER. VISUAL EXAMINATION OF THE UNIT SHOWED NO SIGNS OF DEFECT. A LEAK TEST WAS SUBSEQUENTLY PERFORMED ON THE UNIT BY FILLING THE BLADDER WITH GREEN WATER THEN MONITORED FOR 24 HOURS. AFTER 24 HOURS OF MONITORING PERIOD, NO SIGNS OF GREEN WATER WERE FOUND ANYWHERE OUTSIDE OF THE BLADDER. THEREFORE, THE REPORTED CONDITION OF "LEAKING IN THE HOUSING" COULD NOT BE CONFIRMED. THE ROTO CAUSE IS UNKNOWN. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER HEALTHCARE THAT ONE (1) INFUSOR LV5 DEVICE WAS OBSERVED LEAKING IN THE HOUSING DURING PATIENT USE. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH 5-FLUOROURACIL AND NORMAL SALINE. IT IS UNKNOWN WHERE THE LEAK WAS COMING FROM. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR LV5, 12 PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10H092

    Patients

    Seq Age Sex Outcome Treatment
    1 5-FLUOROURACIL| NORMAL SALINE