BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR LV 5 ML/H

    MDR report key: 1920365 · Received December 10, 2010

    Report

    Report Number
    6000001-2010-05721
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 17, 2010
    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: PER THE CUSTOMER, THE DEVICE WAS LOST IN TRANSIT AND WILL NOT BE RETURNED TO BAXTER FOR EVALUATION; THEREFORE, THE REPORTED CONDITION OF "OVERINFUSION" COULD NOT BE CONFIRMED AND AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED FOR THE REPORT. 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. SHOULD THE DEVICE BECOME AVAILABLE FOR EVALUATION, ANOTHER FOLLOW-UP REPORT WILL BE SUBMITTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) FOLFUSOR LV5 DEVICE HAD OVERINFUSED DURING PATIENT USE. THE DEVICE WAS FILLED WITH 2700 MG OF 5-FLUOROURACIL (5-FU), 400 MG SODIUM-FOLINAT AND 250 ML OF 0.9% SODIUM CHLORIDE. THE DEVICE WAS CONNECTED TO THE PATIENT ON (B)(6) 2010 AT 12:45 PM. IN THE EVENING OF (B)(6) 2010, THE DEVICE WAS CHECKED TO BE PERFORMING OK. AT 8:00 AM ON (B)(6) 2010, THE PATIENT OBSERVED THE DEVICE TO BE EMPTY (TOTAL INFUSION TIME OF 43.25 HOURS WHEREAS EXPECTED IS 48 HOURS). AROUND 2:00 PM (B)(6) 2010, THE PATIENT SUFFERED FROM NAUSEA, SWEATING, AND PAIN (BURNING) IN THE LOWER ABDOMEN. DURING THE EVENING OF (B)(6) 2010, THE PATIENT DRANK MORE LIQUID THAN USUAL AND THEN TOOK A PAIN KILLER IN THE MORNING OF (B)(6) 2010. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLFUSOR LV 5 ML/H PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10E073

    Patients

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