BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 3074789 · Received April 18, 2013

    Report

    Report Number
    9681834-2013-00054
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    CERTIFIED CLINICAL PERFUSIONIST (CCP) FOR TERUMO CARDIOVASCULAR SYSTEMS (TCVS) SPOKE WITH THE PERFUSIONIST ON THE CASE REGARDING THE INCIDENT, INVOLVING AN FX15 OXYGENATOR (1ZZ*FX15RE40A), THAT OCCURRED ON (B)(6) 2013, AT MOBILE INFIRMARY MEDICAL CENTER. SET-UP AND PRIME OF THE CPB CIRCUIT WERE WITHOUT ISSUE; HOWEVER, TWO AIR BUBBLE DETECTORS WERE PLACED ON THE ARTERIAL LINE OF THE CARDIOPULMONARY BYPASS (CPB) CIRCUIT DURING SET-UP. PRIOR TO CPB, THE TUBING WAS ACCIDENTALLY CLAMPED AND THE PRESSURE IN THE CPB CIRCUIT WAS ELEVATED. THE PRESSURE GENERATED WAS HIGHER THAN THE ARTERIAL PRESSURE TRANSDUCER ALARM SET-POINT, AND THE ARTERIAL PUMP STOPPED QUICKLY. THE CARDIOVASCULAR (CV) SURGEON QUICKLY RELEASED THE CLAMP TO RELIEVE THE PRESSURE IN THE ARTERIAL LINE, AND CPB WAS INSTITUTED PER NORMAL PROCEDURE. UPON THE INITIATION OF CPB, THE AIR SENSOR DISTAL TO THE FX15 ALARMED, AND THE ARTERIAL PUMP STOPPED. A BUBBLE WAS OBSERVED IN THE ARTERIAL LINE, AND THE ARTERIAL LINE WAS CLAMPED NEAR THE AORTIC CANNULA. THE PT HAD ADEQUATE BLOOD PRESSURE AND HEART RHYTHM, SO THE SURGEON DISCONNECTED THE AORTIC CANNULA FROM THE ARTERIAL LINE, AND THE AIR WAS REMOVED. THE SURGEON THEN RECONNECTED THE ARTERIAL LINE TO THE CANNULA AND CPB WAS REINITIATED. THE SURGICAL PROCEDURE WAS COMPLETED WITH A DELAY OF APPROX 4 MINUTES IN THE ESTABLISHMENT OF CPB. THERE WAS NO LOSS OF BLOOD ASSOCIATED WITH THIS INCIDENT AND THERE WAS NO HARM OBSERVED. THE PERFUSIONIST STATED THAT THE AIR WAS CREATED IN THE OXYGENATOR WHEN THE ARTERIAL LINE WAS CLAMPED, PRIOR TO CPB, AND A HIGH PRESSURE EVENT WAS CREATED. IN THIS INSTANCE, THE AIR WAS NOT OBSERVED AFTER THE HIGH PRESSURE - QUICK PRESSURE RELEASE EVENT. THE AIR WAS FOUND ON THE INITIATION OF CPB AS THE AIR DETECTOR ALARMED AND THE ARTERIAL PUMP STOPPED. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168597 CAPIOX FX OXYGENATOR BLOOD-GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA NA 120620

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK