BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS DELIVERY SET WITH ARREST/AGENT CASSETTES AND 183CM TABLE LINE

    MDR report key: 5618179 · Received April 28, 2016

    Report

    Report Number
    1649914-2016-00017
    Event Type
    Malfunction
    Date Received
    April 28, 2016
    Date of Event
    March 30, 2016
    Report Date
    March 30, 2016
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    UDI-DI
    00634624521124
    PMA / PMN Number
    K953838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR 5001102-AS LOT #0505176J02 WAS REVIEWED AND THE INSPECTION REPORT SHOWED THAT NO MPS DISPOSABLE SET DEVICE WAS FOUND REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WAS REPORTED SIMILAR TO THIS COMPLAINT CONDITION. ALSO, THE SUB ASSEMBLY PN 801082 LOT#0504685355 & 0504685356 WERE REVIEWED AND NO PART WAS REJECTED FOR THE OCCLUSION OR PARTIAL OCCLUSION. QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S 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 PERFUSIONIST REPORTED AN ISSUE ENCOUNTERED WITH AN MPS DELIVERY SET DURING USE. THERE WERE TWO INCIDENTS DURING THE SAME PROCEDURE, WITH DEVICES FROM THE SAME LOT. REFERENCE MANUFACTURER REPORT NUMBER 1649914-2016-00018 FOR THE SECOND INCIDENT. THIS REPORT STATED THAT FOR THIS FIRST INCIDENT THERE WAS NO LOSS OF MEDICATION BECAUSE THE ARREST AGENT DID NOT GET PAST THE POINT WHERE THE MEDICATION JOINS WITH THE BLOOD IN THE SET. THE ISSUE OCCURRED WHILE THE CROSS CLAMP WAS IN PLACE BUT PRIOR TO DELIVERY OF THE ARREST AGENT. THE PERFUSIONIST STATED THAT AS A RESULT SHE NOTIFIED THE SURGEON WHO REMOVED THE CROSS CLAMP WHILE SHE ATTEMPTED TO TROUBLESHOOT. THE PERFUSIONIST STATED THAT IN ORDER TO ARREST THE HEART SHE REMOVED SOME ADDITIVE FLUID FROM THE ADDITIVE CASSETTE AND REPLACE IT WITH ARREST AGENT AND USED THAT ADDITIVE CASSETTE FOR THE REST OF THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273987 MPS DELIVERY SET WITH ARREST/AGENT CASSETTES AND 183CM TABLE LINE CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5001102-AS 0505176J02 00634624521124

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention