BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CE INFUSOR LV 5, 12 PACK

    MDR report key: 2011476 · Received March 9, 2011

    Report

    Report Number
    6000001-2011-01702
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE WAS NOT DETERMINED. THE ALLEGED OVERINFUSION CONDITION WAS NOT CONFIRMED. UPON RECEIPT, THE UNIT WAS VISUALLY EXAMINED FOR SIGNS OF ABNORMALITY THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION; HOWEVER, NONE WERE FOUND. PER STANDARD PROCEDURE, AN ACCURACY FLOW TEST WAS SUBSEQUENTLY PERFORMED ON THE UNIT FOR 43.5 HOURS. AT THE END OF THE FLOW TEST PERIOD, THE UNIT PRODUCED THE FOLLOWING FLOW RATE (ML/HR): CALCULATED = 5.08, NORMALIZED = 5.20. THE FLOW RATE WAS FOUND TO BE WITHIN THE SPECIFICATION RANGE (4.50 - 5.50 ML/HR) OF THE PRODUCT. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED PRODUCT MET ALL OF THE SPECIFICATIONS FOR RELEASE. 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 SAMPLE HAS BEEN REPORTED TO BE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE CUSTOMER CONTACTED BAXTER TO REPORT AN INCIDENT OF OVERINFUSION WITH AN INFUSOR; THE INFUSOR INFUSED EIGHT (8) HOURS FASTER THAN SCHEDULED. THE PROBLEM WAS NOTED AFTER USE. THE PATIENT WAS INVESTIGATED FOR PERICARDITIS, WAS NOT ADMITTED AND DISCHARGED HOME. THERE WAS NO PATIENT INJURY. SAMPLE IS AVAILABLE FOR EVALUATION. ON (B)(6) 2011 THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER: THE CUSTOMER INDICATED THE PATIENT'S PHYSICIAN STATED IT IS POSSIBLE THAT THE RAPID 5 FLUOROURACIL (FU) INFUSION CAUSED THE PERICARDITIS, BUT CANNOT SAY FOR SURE. THE PATIENT WAS REASSESSED AND NO HARM WAS SUSTAINED AFTER HE WAS TREATED RAPIDLY WITH ASPIRIN. THE PATIENT'S 5FU WAS HELD INDEFINITELY AFTER THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 5, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10K038

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 5 FLUOROURACIL (FU)