BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2901547 · Received January 4, 2013

    Report

    Report Number
    1828100-2013-00019
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    November 12, 2012
    Report Date
    December 18, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TROUBLESHOOTING THE PERFUSIONIST NOTED THE PRESSURE TRANSDUCER LOOKED LIKE IT HAD CORROSION FROM BEING WET. EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THE HOSPITAL IS NOT WILLING TO SHARE ANY FURTHER DETAILS AT THIS TIME. UNTIL FURTHER INFORMATION IS PROVIDED FROM THE CLINICAL TEAM OR OTHER HOSPITAL STAFF, A LINK BETWEEN THE UNPLANNED ARTERIAL PUMP AND PATIENT HARM CANNOT BE ADEQUATELY AND ACCURATELY DETAILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE (CPB), THE PERFUSIONIST (CCP) WAS GETTING A HIGH PRESSURE READING/ALARM WHICH WOULD NOT LET HER GET BACK ON PUMP. PER THE CLINICAL REVIEW: PRIOR TO THE PROCEDURE, DEEP HYPOTHERMIC CIRCULATORY ARREST WAS PLANNED AND THIS IS A COMMON TECHNIQUE FOR THIS TYPE OF REPAIR AND DIAGNOSIS. AFTER THE INITIATION OF CPB, THE PATIENT WAS CORE COOLED WITH A TARGET TEMPERATURE OF 20 DEGREES C PLANNED. AFTER THE AORTIC CROSS-CLAMP WAS APPLIED, THE HEART WAS ARRESTED WITH A CARDIOPLEGIC SOLUTION. AFTER THE ARREST, THE PATIENT CONTINUED TO BE COOLED AND A HIGH ARTERIAL PRESSURE ALARM OCCURRED WHEN THE PATIENT WAS AT 21 DEGREES C NASOPHARYNGEAL (NP). THE HIGH PRESSURE ALARM STOPPED THE ARTERIAL PUMP, AS PER CONFIGURED BY THE CLINICAL TEAM. THE PRESSURE DISPLAYED ON THE CENTRAL CONTROL MONITOR (CCM) WAS 999 MMHG. EVEN AFTER THE PUMP STOPPED, THE PRESSURE WAS DISPLAYED AS 999 MMHG. THE CCP ATTEMPTED TO RE-ZERO THE TRANSDUCER AND CLEAR THE ALARM, BUT THE PRESSURE CONTINUOUSLY DISPLAYED 999 MMHG. THIS ALARM CONDITION DID NOT ALLOW A RE-START OF THE ARTERIAL PUMP. AFTER CONTINUED TROUBLESHOOTING, THE CCP ELECTED TO DISCONNECT THE PRESSURE TRANSDUCER FROM SYSTEM AND THEN THE ARTERIAL PUMP WAS ABLE TO BE RE-STARTED. THE ARTERIAL PUMP WAS OFF FOR SIX MINUTES. THE CARDIOVASCULAR (CV) TEAM ELECTED TO NOT HAND CRANK THE ARTERIAL PUMP DURING THIS INCIDENT WITH FEAR OF DAMAGE OF THE DISEASED AND WEAKENED AORTA. WHEN THE ARTERIAL PUMP WAS RE-STARTED, CORE COOLING CONTINUED FOR AN ADDITIONAL FIVE MINUTES AND THEN CIRCULATORY ARREST (PLANNED, INTENTIONAL STOP OF THE ARTERIAL PUMP) WAS PERFORMED. THE ARTERIAL LINE PRESSURE TUBING WAS MOVED TO THE CARDIOPLEGIA PRESSURE TRANSDUCER IN ORDER TO PROVIDE PRESSURE MONITORING OF THE ARTERIAL LINE OF THE CIRCUIT. SINCE THE TEAM ELECTED NOT TO REASSIGN THE CARDIOPLEGIA PRESSURE TRANSDUCER TO ARTERIAL STATUS, ANY HIGH PRESSURES IN THE ARTERIAL LINE WOULD NOT LEAD TO AUTOMATIC PUMP STOPPAGE OF THE ARTERIAL PUMP. AFTER A CIRCULATORY ARREST PERIOD OF ELEVEN MINUTES, THE ARTERIAL PUMP WAS RE-STARTED AND CPB WAS RE-INSTITUTED. THE PATIENT WAS SLOWLY RE-WARMED ON CPB AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS ASSOCIATED WITH THE EVENT. NO FURTHER ISSUES SURFACED DURING CPB AND THE PATIENT WAS WEANED FROM CPB WITHOUT LOSS OF BLOOD OR NEEDED TRANSFUSION DUE TO THIS SPECIFIC INCIDENT. THE PROCEDURE (INCLUDING CPB TIME) WAS DELAYED FOR SIX MINUTES AS THE HIGH PRESSURE ALARM CONDITION WAS BEING INVESTIGATED AND MITIGATED. THE PATIENT DID EXPIRE AFTER THE PROCEDURE WAS COMPLETED AND THE CCP STATED THAT THE DEATH WAS UNRELATED TO THE REPORTED SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4081 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 16433301

    Patients

    Seq Age Sex Outcome Treatment
    1 Death