BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BABY RX05 OXY W/HR

    MDR report key: 3143001 · Received May 30, 2013

    Report

    Report Number
    9681834-2013-00069
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ASHITAKA FACTORY OF TERUMO CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K022115
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVAL; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFO BECOMES AVAILABLE. FOR THIS REASON, TERUMO REFERENCES EVAL CODES. (B)(4).

    Description of Event or Problem · 1

    A SEVEN MONTH OLD PATIENT WAS BROUGHT IN FOR SURGERY FOR A PULMONARY INFUNDIBULAR ENLARGEMENT. THE CERTIFIED CLINICAL PERFUSIONIST (CCP) ON THE CASE USED A SYRINGE TO PURGE THE LINE AS THERE WAS TROUBLE INITIALLY PRIMING THE UNIT. THE CCP PERFORMED A PRE-BYPASS ULTRAFILTRATION FOR 30 MINUTES AND NOTED NO PATIENT MANAGEMENT DIFFICULTIES. THE CCP INITIATED CARDIOPULMONARY BYPASS (CPB) WITH A FRACTION OF INSPIRED OXYGEN (FIO2) LEVEL OF 80 PERCENT, AND WHEN OXYGENATION PROBLEMS WERE NOTED THE LEVEL WAS INCREASED TO 100 PERCENT. WHILE AT A 60 CC/MINUTE BLOOD FLOW RATE, THE LINE PRESSURES OF THE UNIT WERE 150MM TO 180MM RANGE. THE INITIAL PARTIAL PRESSURE OF OXYGEN (PO2) LEVEL WAS APPROX 63, AND THE CCP PERFORMED TROUBLESHOOTING ON THE GAS SYSTEM. NO ABNORMALITIES WERE FOUND, AND NO ALARMS WERE NOTED. FORTY THREE MINUTES INTO THE PROCEDURE, THE CCP DECIDED TO CHANGE OUT THE OXYGENATOR. THE CHANGE OUT RESULTED IN A 13 MINUTE DELAY AND APPROXIMATELY 40ML OF BLOOD LOSS. ADD'L HEPARIN WAS GIVEN, AND THE PROCEDURE PROCEEDED NORMALLY. ON (B)(4), THE PATIENT WAS DOING WELL AND THE CUSTOMER REPORTED NO INJURY. TERUMO DEEMS ANY BLOOD LOSS ON A PEDIATRIC OR YOUNGER PATIENT AS AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239685 BABY RX05 OXY W/HR BLOOD-GAS OXYGENATOR DTZ ASHITAKA FACTORY OF TERUMO CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Required Intervention