BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3922176 · Received July 9, 2014

    Report

    Report Number
    1416980-2014-21901
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND NO SIGNS OF PHYSICAL ABNORMALITY THAT COULD HAVE CAUSED THE REPORTED PROBLEM. A FLOW RATE TEST WAS PERFORMED, AND THE FLOW RATE WAS FOUND TO BE WITHIN THE SPECIFICATION RANGE OF THE PRODUCT. THE REPORTED CONDITION WAS UNABLE TO BE VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPH DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. IN ADDITION, A PHOTOGRAPH HAS BEEN RECEIVED FOR EVALUATION. THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME INFUSOR UNDER INFUSED. THIS OCCURRED DURING INFUSION OF FLUOROURACIL. THE REPORTER STATED THAT ¿AT THE END OF THE INFUSION THERE WAS STILL AN AMOUNT OF SOLUTION INSIDE THE BLADDER.¿ THE CUSTOMER REPORTED THAT THE WEIGHT OF MEDICATION IN THE DEVICE BEFORE INFUSION WAS 95.63 G; AFTER THE EXPECTED THERAPY TIME, THERE WAS 72.53 G OF SOLUTION REMAINING IN THE DEVICE. IT WAS FURTHER REPORTED THAT ONLY 639.15 MG OF FLUOROURACIL WERE INFUSED INTO THE PATIENT RATHER THAN THE EXPECTED 2646 MG. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401795 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11J001

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL