BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPS DELIVERY SET W AA AND ADD CASSETTES

    MDR report key: 3308570 · Received August 19, 2013

    Report

    Report Number
    1649914-2013-00041
    Event Type
    Injury
    Date Received
    August 19, 2013
    Date of Event
    July 22, 2013
    Report Date
    July 22, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A POSSIBLE LEAKAGE ISSUE WITH AN MPS DISPOSABLE DELIVERY SET. THE PERFUSIONIST REPORTED SHE HAD PRIMED THE SYSTEM AND HAD THE CONSOLE IN RECIRCULATION MODE WHEN THE CONSOLE DISPLAYED THE "EXCESSIVE INLET PRESSURE CHECK SOURCE LINE" ALARM CODE. IT WAS REPORTED THE PERFUSIONIST PERFORMED SOME TROUBLE-SHOOTING, INCLUDING POWERING THE CONSOLE OFF AND BACK ON AGAIN. WHILE POWERING THE CONSOLE BACK ON, THE PERFUSIONIST REPORTED OBSERVING FLUID AT THE BASE OF THE UNIT, NEAR THE UNIT POWER SWITCH. THE PROCEDURE HAD NOT YET STARTED, SO THE DISPOSABLE WAS EXCHANGED FOR ANOTHER PRIMED AND COMPLETED THE PROCEDURE WITHOUT COMPLICATIONS. THERE WAS NO PT INVOLVEMENT OR HARM REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DISPOSABLE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401022 MPS DELIVERY SET W AA AND ADD CASSETTES CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102 0442983Y07

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention