BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET W AA AND ADD CASSETTES

    MDR report key: 3042425 · Received December 5, 2012

    Report

    Report Number
    1649914-2012-00034
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 27, 2012
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE HOSP PERFUSIONIST REPORTED ON (B)(6) 2012 THAT BLOOD LEAKED FROM THE IN-FLOW SIDE OF THE HEAT EXCHANGER DURING A PROCEDURE. SHE REPORTED THIS OCCURRED WITH TWO HEAT EXCHANGERS OF THE SAME LOT. (REF MFR REPORT 1649914-2012-00026). IT WAS REPORTED THAT THE BLOOD LEAK INVOLVED A "MINISCULE" LOSS OF BLOOD AND THE PROCEDURE SUCCESSFULLY COMPLETED USING THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS RETURNED TO THE MFR FOR ANALYSIS ON (B)(6) 2012. THE MFR RECEIVED A COPY OF THE APPLICABLE USER FACILITY REPORT ON (B)(6) 2012 WHICH INDICATED A "WATER TO BLOOD" LEAK INSTEAD. THAT ALLEGED CONDITION COULD NOT BE VERIFIED WITH THE HOSP RISK MANAGEMENT OFFICE, WHOSE INFO ONLY SUPPORTED THE "BLOOD TO ATMOSPHERE" LEAK CONDITION THAT WAS INITIALLY REPORTED. F/U WITH THE INITIAL REPORTER (PERFUSIONIST) ALSO CONFIRMED THE EVENT DID NOT INVOLVE WATER-TO-BLOOD. BASED ON THAT CONFIRMATION AND ALSO THE ANALYSIS OF BOTH RETURNED DEVICES BY THE MFR, THE EVENT DESCRIPTION IN THE USER FACILITY REPORT FILED WITH FDA WAS INCORRECT. THIS REPORT IS BEING FILED TO PROVIDE THE CORRECT INFO REGARDING THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPS DELIVERY SET W AA AND ADD CASSETTES CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0424462U02

    Patients

    Seq Age Sex Outcome Treatment
    1