BEUDAMED
    FDA Adverse Event Death Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2934423 · Received January 11, 2013

    Report

    Report Number
    1828100-2013-00047
    Event Type
    Death
    Date Received
    January 11, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, BUT NOT YET COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE (CPB), THE CARDIOPLEGIA LINE BURST. THE PERFUSIONIST (CCP) STATED "THE CARDIOPLEGIA LINE WAS LYING NEAR/ON THE SYSTEM 1 LAMP. THE LINE WAS VERY HOT DUE TO THE LAMP." PER THE CLINICAL REVIEW: THIS WAS AN EMERGENT PATIENT AND THE CCP REPORTED DAMAGE TO THE CARDIOPLEGIA DELIVERY LINE DURING CPB. AFTER THE AORTIC CROSS-CLAMP HAD BEEN REMOVED DURING THE REWARMING PHASE OF CPB, THE CCP HEARD A "POPPING SOUND" AND DISCOVERED THAT THE CARDIOPLEGIA DELIVERY LINE HAD BEEN DAMAGED AND IT APPEARED THAT THE DELIVERY LINE WAS HEATED-UP DUE TO CLOSE PROXIMITY TO THE LAMP OF THE PERFUSION SYSTEM UNIT. SINCE THE AORTIC CROSS-CLAMP WAS REMOVED, AT THE TIME, THERE WERE NO PLANS TO DELIVER ANY MORE CARDIOPLEGIA. HOWEVER, THE CARDIOVASCULAR (CV) SURGEON MADE THE DECISION TO RE-CROSS CLAMP THE AORTA AND TO DELIVER MORE CARDIOPLEGIA. WITH THIS CHANGE IN PLANS, THE CCP NEEDED TO REMOVE THE DAMAGED CARDIOPLEGIA DELIVERY LINE, CONNECT AND PRIMED A NEW CARDIOPLEGIA DELIVERY LINE. ACCORDING TO THE CCP, THIS DELAYED THE CROSS-CLAMPING AND DELIVERY OF THE CARDIOPLEGIA DOSE BY TWO MINUTES. THE CCP STATED THIS DELAY DID NOT IMPACT THE PATIENT. THE SURGICAL PROCEDURE WAS COMPLETED, AND THERE WAS NO LOSS OF BLOOD ASSOCIATED WITH THIS INCIDENT. THE PERFUSIONIST STATED THE PATIENT DID EXPIRE LATER IN THE OPERATING ROOM. THE ISSUE WITH THE CARDIOPLEGIA DELIVERY LINE HAD NO RELEVANCE TO THE DEATH OF THE PATIENT. INTERVENTION INCLUDED REMOVAL OF THE DAMAGED CARDIOPLEGIA TUBING AND REPLACEMENT WITH A NEW DELIVERY LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19214 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 150607

    Patients

    Seq Age Sex Outcome Treatment
    1 Death