BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DISPOSABLE

    MDR report key: 3912344 · Received May 13, 2014

    Report

    Report Number
    1649914-2014-00021
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 15, 2014
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOREIGN DISTRIBUTOR ((B)(6)) REPORTED A LEAKAGE ISSUE WITH THE MPS DISPOSABLE DELIVERY SET FROM ONE OF THEIR CUSTOMERS. THE HOSPITAL REPORTED A LEAKAGE ORIGINATING AT THE CONNECTION BETWEEN THE ARREST AGENT CASSETTE AND THE HEAT EXCHANGER. IT WAS REPORTED THAT THE HOSPITAL STAFF ATTEMPTED TO TIGHTEN THE CONNECTOR AT THAT JOINT; HOWEVER, THE ALLEGED LEAKAGE OF ARREST AGENT CONTINUED. IT WAS REPORTED THAT THE DISPOSABLE SET WAS USED FOR THE ENTIRE PROCEDURE WITH NO IMPACT TO THE PATIENT. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THE ALLEGED EVENTS. THE LOT NUMBER OF THE DEVICE WAS NOT KNOWN. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285491 MPS DISPOSABLE CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention