BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADROX-ID ADULT OXYGENATOR WITH BIOLINE COATING WITH SCREW CONNECTOR

    MDR report key: 10344203 · Received July 30, 2020

    Report

    Report Number
    8010762-2020-00243
    Event Type
    Death
    Date Received
    July 30, 2020
    Date of Event
    July 13, 2020
    Report Date
    September 21, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K150267
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INVOLVED OXYGENATORS WERE DISPOSED BY THE CUSTOMER BECAUSE AS THEY STATED: "WE DO NOT FEEL THAT THE PRODUCT WAS FUNCTIONING ABNORMALLY, WE ARE SEEKING TO UNDERSTAND THE CONDITIONS THAT COULD HAVE LED TO THE NEED FOR OXYGENATOR REPLACEMENT." A MEDICAL REVIEW WAS PERFORMED BY MANAGER MEDICAL AFFAIRS ON 2020-09-18: DESPITE THE ADMINISTRATION OF HEPARIN, ACCORDING TO THE DOCUMENTATION PROVIDED, THE PATIENTS PTT LEVELS WERE MAINTAINED CLOSE TO A NORMAL LEVEL (29-47) RATHER THAN THE RECOMMENDED 1.5  2.5 TIMES THE NORMAL VALUE ANTICIPATED DURING ECLS SUPPORT. ALTHOUGH NO THROMBUS OR CLOT WAS VISIBLE WITHIN THE CIRCUIT, ELEVATED D-DIMER LEVELS MAY BE INDICATIVE OF A CLOT BURDEN, WHETHER LOCATED WITHIN THE ECLS CIRCUIT, OR ELSEWHERE IN THE PATIENTS VASCULAR SYSTEM (I.E. DEEP VEIN THROMBOSIS, PULMONARY EMBOLISM). WHILE THE ADMINISTRATION OF BLOOD PRODUCTS DURING ECMO ARE FREQUENTLY NECESSARY, BLOOD PRODUCTS CONTAINING PRECOAGULATION ELEMENTS (E.G. PLATELETS) AND MAY SERVE TO ACCELERATE THE COAGULATION CASCADE, RESULTING IN UNEXPECTED RESULTS IN THE EXTRACORPOREAL CIRCUIT. DURING THE PERIOD OF FREQUENT EXCHANGE 7/13-7/19 THE PATIENT REPORTEDLY DID RECEIVE PLATELETS DAILY, AS WELL AS THREE UNITS PRBCS. PER FURTHER INQUIRY, DETAIL WAS PROVIDED THAT AN IN-LINE HEMOFILTER WAS USED FOR SLOW CONTINUOUS ULTRAFILTRATION (SCUF). THIS MAY HAVE SERVED AS A SOURCE FOR FURTHER HEMOLYSIS OR THROMBUS FORMATION CONTRIBUTING TO THE NEED FOR THE FINAL TWO OXYGENATOR EXCHANGES. ELEVATED PLASMA FREE HEMOGLOBIN CAN BE INDICATIVE OF HEMOLYSIS AND NOTABLY THE PATIENTS LEVELS WERE ELEVATED DURING THE FOUR DAYS OF THIS COMPLAINTS EXAMINATION PERIOD. ELEVATED PLASMA FREE HEMOGLOBIN LEVELS FOR PATIENTS ON ECMO MAY BE INDICATIVE OF A CLOT BURDEN OR BUILDUP WITHIN THE ECMO CIRCUIT. IT WAS NOTED BY THE CUSTOMER THAT THE PATIENTS PFHB LEVELS WERE ELEVATED (100-170) THE FOUR DAYS THIS COMPLAINT ADDRESSED. IT IS LIKELY BOTH THE PATIENTS ACUTE ILLNESS, TRANSFUSION HISTORY, LENGTH OF THERAPY AND PRO-THROMBOTIC STATE THAT MAY HAVE ALL CONTRIBUTED TO THE EVENTS. THUS THE ISSUE COULD BE CONFIRMED BUT NO PRODUCT RELATED MALFUNCTION. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARYS TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 1

    (B)(4). NOTE: THE QUADROX-ID PEDI WILL BE HANDLED UNDER COMPLAINT RECORD#(B)(4), EMDR # (B)(4).

    Description of Event or Problem · 1

    CUSTOMER HAD A 3 KG, CDH, POST-REPAIR PATIENT ON ECMO. SHE HAD BEEN ON FOR 4.5 WEEKS. WE DID A CIRCUIT CHANGE ON 7/13 DUE TO INCREASING DELTA P (MEMBRANE HAD CLOTTED OF ON THE PREVIOUS CIRCUIT DUE TO A LARGE CLOT BREAKING LOOSE POST PUMP HEAD AND OCCLUDING THE OXY INLET). THE DELTA P ON THE NEW CIRCUIT WAS 15-20MMHG, 48 HOURS IN, THE DELTA P ACUTELY INCREASED TO 40 THEN BEGAN QUICKLY INCREASING BY 1MMHG ABOUT Q5 MINUTES. WE CHANGED THE MEMBRANE ON 7/16 AT 0100, AT 2200 THE DELTA ON THE NEW PEDI WAS AGAIN 90 AND CLIMBING, WE CHANGED TO AN ADULT OXY. ON 7/18 (AROUND 0500, SAME THING, QUICK INCREASE (DOUBLE) OF THE DELTA P, AND CONTINUED FAST INCREASE. CHANGED THE OXY AGAIN, BACK TO A PEDI, AT 2100, HAD TO CHANGE AGAIN AND THEN ON 7/19 AT 0700 WAS CHANGE AGAIN. ALL OF THEM HAD THE APPEARANCE AS SEEN. THE REST OF THE CIRCUIT WAS CLEAN, NOT EVEN CLOT AT THE CONNECTORS. HER ANTIXA WAS 0.22-0.35, FIBRINOGEN >300, AT3 60-90, D-DIMER HAD BEEN >20 ON 7/16, BUT DECREASED TO 15, 11, 8 ON SUBSEQUENT DAYS 7/17, 7/18, AND 7/19, HER APPT WAS 50-90. SHE DID RECEIVE 20ML/KG OF PLATELETS EACH DAY, AS HER PLATELET GOAL WAS >150 (I KNOW!) AND SHE RECEIVED PRBCS 3 TIMES DURING THIS 4 DAY STRETCH. HER PFH INCREASED FROM 100 TO 170 OVER THE 4 DAYS. PATIENT EXPIRED, BUT ACCORDING TO THE CUSTOMER, THIS WAS NOT DUE TO THE CIRCUIT CHANGES. COMPLAINT ID: (B)(4). NOTE: THE QUADROX-ID PEDI WILL BE HANDLED UNDER COMPLAINT RECORD# (B)(4), EMDR# 345051.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812052 QUADROX-ID ADULT OXYGENATOR WITH BIOLINE COATING WITH SCREW CONNECTOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HMOD 70000-USA #SQUADROX-ID ADULT O.FILT

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Death