BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESCRIPTIVE OXY PACK - CAPIOX

    MDR report key: 6747625 · Received July 27, 2017

    Report

    Report Number
    1124841-2017-00157
    Event Type
    Injury
    Date Received
    July 27, 2017
    Date of Event
    July 4, 2017
    Report Date
    October 26, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED. THE PUMP RECORD WAS RECEIVED AND REVIEWED FOR THIS CASE; THEREFORE, ALL THE PATIENT RELATED INFORMATION WAS ADDED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON JULY 27, 2017. (B)(4). VISUAL INSPECTION UPON RECEIPT DID NOT FIND ANY ANOMALIES WHICH WOULD RELATE TO A GAS LEAK OR INSUFFICIENT GAS TRANSFER PERFORMANCE. DHR REVIEWED DID NOT IDENTIFY AN PRODUCTION RELATED ISSUES. NO ANOMALIES WERE REVEALED IN THE GAS TRANSFER PERFORMANCE OF THE ACTUAL SAMPLE, WITH THE OBTAINED VALUES MEETING THE FACTORY SPECIFICATIONS. DURING TEST, THE COLORS OF THE VENOUS AND ARTERIAL BLOOD WERE OBSERVED. THE ARTERIAL BLOOD WAS FOUND TO HAVE BECOME BRIGHT RED. THE INVESTIGATION RESULT VERIFIED THAT THE RETURNED SAMPLE WAS THE NORMAL PRODUCT WITH NO ISSUE IN THE GAS TRANSFER PERFORMANCE. BASED ON THE PHOTOS THAT SHOW THE CLOT FORMATION IN THE ACTUAL SAMPLE, IT IS ASSUMABLE THAT THE CLOTS FORMED INSIDE THE ACTUAL SAMPLE HINDERED THE GASES FROM BEING TRANSFERRED SUFFICIENTLY. THE CIRCULATION CONDITIONS AND THE TIMING OF THE OCCURRENCE OF THIS EVENT ARE UNKNOWN, THEREFORE, THE CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED DEFINITELY. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE PUMP RECORD WAS RECEIVED FOR THIS CASE AND REVIEWED. THERE WERE SOME VENTILATION ISSUES CONSIDERING THE PCO2 VALUES, DECREASE IN PH AND LOWER PO2 VALUES THAN NORMALLY SEEN WITH ANESTHESIA¿S BLOOD GASES. THE LACTATE LEVELS STEADILY INCREASED FROM 1705 ¿ 2056 INDICATING THERE WAS ANAEROBIC METABOLISM TAKING PLACE. THE ACT WAS 449 AT 2015 AND 5,000 UNITS OF HEPARIN WAS GIVEN AT 2025 BUT THEY DIDN¿T GO ON BYPASS UNTIL 2104 (39 MINUTES). THE PATIENT WAS 120 KG. THERE WAS 10,000 UNITS OF HEPARIN IN THE PUMP PRIME.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE ARTERIAL BLOOD WAS DARK. *BLOOD LOSS OF 240 ML. *PRODUCT WAS CHANGED OUT. *2 MINUTES DELAY. *PROCEDURE COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS PROVIDED TO TERUMO BY THE USER FACILITY REGARDING THE REPORTED EVENT. THE OXYGENATOR WAS CHANGED OUT APPROXIMATELY 2 MINUTES INTO BYPASS. THERE WAS APPROXIMATELY 240 ML OF BLOOD LOSS AND THEY WERE OFF BYPASS FOR APPROXIMATELY 2 MINS. THE PROCEDURE WAS A HEART TRANSPLANT. THEY WENT ON BYPASS AND THE SURGEON CROSS-CLAMPED QUICKLY. THEY WERE STRUGGLING TO VENTILATE THE PATIENT PRIOR TO CPB. PRIOR TO CPB THEY PERFORMED RAP AND HAD SOME BLOOD IN THE RESERVOIR FROM PUMP SUCKER RETURN FROM THE CHEST CAVITY. THE PERFUSIONIST WAS RECIRCULATING THE BLOOD PRIOR TO CPB AND THE BLOOD WAS BRIGHT RED. THEY WENT ON BYPASS AND WERE ABLE TO FLOW ADEQUATELY AT ~ 6 LPM. THE BLOOD WAS DARK AND WAS NOT TURNING RED AFTER A COUPLE MINUTES ON BYPASS SO THEY BYPASSED THE VAPORIZER AND RAN THE OXYGEN LINE DIRECTLY INTO THE OXYGENATOR GAS INLET PORT. THIS RESULTED IN NO CHANGE IN OXYGENATION SO THEY CHECKED ALL CONNECTIONS WHICH WERE ALL OKAY, NO LEAKS NOTED. THEY DECIDED TO CHANGE OUT THE OXYGENATOR WHICH RESULTED IN AN APPROXIMATE TIME OFF CPB OF ABOUT 2 MINS. THE ACT WAS 412 SECONDS PRIOR TO CPB BUT IT HAD BEEN A LONG TIME (EXACT TIME UNKNOWN) SINCE HEPARIN ADMINISTRATION TO THE TIME CPB WAS INITIATED. THE PATIENT WAS DOING FINE POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528376 PRESCRIPTIVE OXY PACK - CAPIOX CARDIOVASCULAR PROCEDURE KIT OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 74284 VE17

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other