BEUDAMED
    FDA Adverse Event Death Summary report: N

    TUBING SET

    MDR report key: 17486124 · Received August 9, 2023

    Report

    Report Number
    8010762-2023-00384
    Event Type
    Death
    Date Received
    August 9, 2023
    Date of Event
    July 26, 2023
    Report Date
    October 24, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE BLOOD CHANGED COLORS IN BOTH TUBES. THE MONITORING OF THE ARTERIAL AND VENOUS LINE WAS CONTINUED. THE PATIENTS SATURATION WAS BELOW 70% AT 100% FIO2. PO2 VALUES WERE LOW AFTER 24 HOURS OF BEGINNING ECMO FOR ALL THREE PATIENTS. THE POST MEMBRANE SAMPLE WAS SHOWING LOW PO2 VALUES. THE OXYGENATOR WAS EXCHANGED IN ALL EVENTS. THE PATIENT EXPIRED. THE EVENTS WILL BE INVESTIGATED IN FOLLOWING COMPLAINTS: TW ID# (B)(4) (MFG REPORT NUMBER 8010762-2023-00383), #(B)(4) (MFG REPORT NUMBER 8010762-2023-00382), #(B)(4) (MFG REPORT NUMBER 8010762-2023-00384). ALL AFFECTED HLS SETS WERE DISCARDED BY THE CUSTOMER. THE CUSTOMER CONFIRMED THAT THE PATIENTS EXPIRED DUE TO THEIR ASSOCIATED COMORBIDITIES. FOUR UNUSED HLS SETS FROM THIS CUSTOMER WERE RETURNED FOR MANUFACTURERS LABORATORY INVESTIGATION AND WERE INVESTIGATED ON 2023-10-20. DELIVERY CONDITIONS OF THE SETS WITH LOT # 3000261048 : TWO SETS WERE NOT DELIVERED IN THE ORIGINAL OUTER PACKAGING. ONE SET WAS ALREADY OPENED WHEN DELIVERED. ONE SET WAS DELIVERED IN ORIGINAL CONDITION. THE SETS WERE EXPIRED WHEN DELIVERED AND WERE OUTSIDE THE SHELF LIFE DURING THE TESTS AND THE SEALING PROPERTIES OF THE PVC HOSES DO NOT CORRESPOND TO THE AS-DELIVERED CONDITION. ALL HLS SETS PASSED THE TIGHTNESS TEST OF THE BLOOD SIDE, THE TIGHTNESS TEST OF WATER SIDE, HAD CONTINUOUS FLOW AND ALL INTEGRATED SENSORS WERE FUNCTIONAL. 2 HLS SETS SHOWED A LEAKAGE AT THE GAS FILTER TUBING DURING THE TIGHTNESS TEST ON THE GAS SIDE. THE TEST PRESSURE VALUE IS TEN TIMES HIGHER THAN THE APPLICATION PRESSURE USUALLY IS USED. 2 HLS SETS ALSO PASSED THIS TIGHTNESS TEST. THEREFORE, THE EXACT ROOT CAUSE REMAINS UNKNOWN. A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON 2023-10-23 WITH FOLLOWING CONCLUSION: ¿THE SPARSE COMPLAINT NARRATIVE DESCRIBES THREE CASES OF HYPOXEMIA DURING ONGOING SUPPORT, PERSISTING EVEN AT 24 HOURS AND AFTER OXYGENATOR EXCHANGE IN ALL THREE CASES. A HIGH BODY SURFACE AREA [BSA] (2.4M² AND 2.5M²) FOR TWO CASES (COMPLAINT NUMBERS (B)(4)) IS OBSERVED IN BOTH COMPLAINT NARRATIVES. VENO-VENOUS SUPPORT IS PRESUMED FOR THESE ACCOUNTS RELATIVE TO THE ASSOCIATED DISEASE PROCESSES (ARDS AND ARDS/H1N1) CITED IN THESE PATIENTS. THE THIRD CASE (COMPLAINT NUMBER (B)(4)) CITED A MODERATE BSA OF 1.7M² WITH A PRESUMED SUPPORT VENUE OF VENO-ARTERIAL, GIVEN THE ATTENDANT DISEASE PROCESS (VIZ., CARDIOGENIC SHOCK, HYPOTENSION, LV DYSFUNCTION). THE FOLLOWING BELOW IS TO REFLECT THE OPERATING CAPACITIES OF THE PRODUCT RELATIVE TO THE PROJECTED TARGET FLOWS EACH PATIENT RELATIVE TO BSA: - COMPLAINT NUMBER (B)(4): BSA (M2) = 2.4, PERFUSION/ CARDIAC INDEX USED (L/MIN/M2) = 2.2 ¿ 2.4, TARGET FLOW (CALCULATED BSA X CARDIAC INDEX) = 5.3 ¿ 5.8 LPM, RATED FLOW OF THE HLS 5050² = 0.5- 5.0 LPM. - COMPLAINT NUMBER (B)(4): BSA (M2) = 2.5, PERFUSION/ CARDIAC INDEX USED (L/MIN/M2) = 2.2 ¿ 2.4, TARGET FLOW (CALCULATED BSA X CARDIAC INDEX) = 5.3 ¿ 6.0 LPM, RATED FLOW OF THE HLS 5050² = 0.5- 5.0 LPM. - COMPLAINT NUMBER (B)(4): BSA (M2) = 1.7, PERFUSION/ CARDIAC INDEX USED (L/MIN/M2) = 2.4 ¿ 2.8, TARGET FLOW (CALCULATED BSA X CARDIAC INDEX) = 4.1 ¿ 4.8 LPM, RATED FLOW OF THE HLS 5050² = 0.5- 5.0 LPM. A STANDARD CARDIAC INDEX (RANGE) WAS SELECTED FOR THE FIRST TWO CASES, WHILE A HIGHER PERFUSION INDEX (RANGE) WAS SELECTED IN THE THIRD COMPLAINT TO ACCOMMODATE VENO-ARTERIAL SUPPORT WITH VASOPLEGIA. A CURSORY GLANCE OF THE NECESSARY TARGET FLOWS FOR TWO (2) PATIENTS (COMPLAINT NUMBERS (B)(4)) SHOWS THE TARGET FLOWS (USING CUSTOMARY PERFUSION /CARDIAC INDEX VALUES) WERE HIGHER THAN THE RATED FLOW OF THE HLS 5050 PRODUCT. USING FLOWS HIGHER THAN THE RATED FLOW OF THE PRODUCT SIGNIFICANTLY DECREASES INTRA-OXYGENATOR TRANSIT/DWELL TIME, WHICH CAUSES A PRECIPITOUS DECREASE IN OXYGEN TRANSFER AND CARBON DIOXIDE REMOVAL WITHIN THE MEMBRANE. USING A TARGET FLOW THAT IS GREATER THAN THE RATED FLOW MAY PROVIDE A POSSIBLE ROOT CAUSE FOR THE LOW PO2S CITED BY THE CUSTOMER IN COMPLAINT NUMBERS (B)(4). THAT SAID, IT IS POSSIBLE THAT THE CUSTOMER DECIDED TO EMPLOY A ¿LEAN FLOW¿ TECHNIQUE WHICH RECALIBRATES TARGET FLOW BASED ON A CALCULATION OF LEAN BODY MASS. HOWEVER, IT IS ADVISABLE TO CAREFULLY MONITOR OXYGEN DELIVERY (DO2), VENOUS SATURATION (SVO2), OXYGEN CONSUMPTION (VO2), AND CO2 PRODUCTION WHEN USING THIS TECHNIQUE TO ASSURE ADEQUATE PERFUSION OF THE PATIENT. NO DATA WAS PROVIDED BY THE CUSTOMER PERTAINING TO HOW/IF THESES VARIABLES WERE MONITORED DURING THE COURSE OF SUPPORT EITHER WITH OR WITHOUT A LEAN BODY MASS APPROACH TO PERFUSION. IT WAS STATED THAT THE EXPIRATION OF THE PATIENTS IN BOTH OF THE ABOVE SCENARIOS (I.E., COMPLAINT NUMBERS (B)(4)) WAS SECONDARY TO EXISTING COMORBIDITIES. A PRODUCT-RELATED CAUSE OF EXPIRATION WAS NOT IMPLIED. COMPLAINT NUMBER (B)(4) DESCRIBED THE PATIENT AS SUBJECT TO CARDIOGENIC SHOCK, HYPOTENSION (VASOPLEGIA), AND LEFT VENTRICULAR (LV) DYSFUNCTION. (B)(6) ET AL4, RECOMMENDS THE DEPLOYMENT OF LV UNLOADING IN THE FACE OF LV DYSFUNCTION DURING ECMO/ECLS. METHODS OF LV UNLOADING INCLUDE HEMOFILTRATION, IABP, IMPELLA, ETC. 4 THE NEED, AS WELL AS BENEFITS, OF LV VENTING IN A SEVERELY DYSFUNCTIONAL HEART THAT DOES NOT GENERATE AN EFFECTIVE EJECTION, OR THAT IS MARKEDLY DILATED, IS FAIRLY WELL ESTABLISHED IN EXISTING LITERATURE. 5 WHILE ECMO/ECLS IS LIKELY THE MOST WIDELY USED THERAPY FOR CARDIOGENIC SHOCK (CGS), RAPID DETERIORATION OF THE PATIENT IN CGS IT IS OFTENTIMES ASSOCIATED WITH HIGH MORTALITY. 6 THAT SAID, IT IS UNCLEAR WHETHER LV UNLOADING WAS DEPLOYED IN THIS CASE. FURTHER, LOWER PAO2S ARE RECOMMENDED BY SOME AUTHORS FOR PATIENTS IN CGS SUPPORTED BY ECMO/ECLS AS HIGHER PAO2S MAY BE ASSOCIATED WITH INCREASED HOSPITAL MORTAILITY.7 LAST, IT WAS STATED THAT THE EXPIRATION OF THE PATIENT (I.E., COMPLAINT NUMBER (B)(4)) WAS SECONDARY TO EXISTING COMORBIDITIES. A PRODUCT-RELATED CAUSE OF EXPIRATION WAS NOT IMPLIED IN THE THIRD COMPLAINT NARRATIVE OR CORRESPONDENCE. DUE TO THE LACK OF INFORMATION PROVIDED; IT IS NOT POSSIBLE TO ADEQUATELY ASSESS THE PERFORMANCE OF THE PRODUCT (VIZ., THE MEMBRANE), ESPECIALLY IN VIEW OF THE PATIENT COMORBIDITIES. AS THE QUESTIONNAIRE WAS NOT RETURNED, IT IS CHALLENGING TO GAUGE/PRESUME THE OXYGEN CONSUMPTION, OXYGEN DELIVERY, AND OXYGEN TRANSFER. FURTHER, IN THESE SITUATIONS AN OXYGEN TRANSFER CALCULATION MAY BE PERFORMED TO DETERMINE THE SOURCE OF LOW PO2 (I.E., THE OXYGEN TRANSFER IN THE MEMBRANE AND/OR THE OXYGEN CONSUMPTION IN THE PATIENT). REGARDING THE TESTING OF THE FOUR (4) HLS 5050 SETS RETURNED TO GETINGE FOR INSPECTION, THE LIFE-CYCLE ENGINEERING REPORT STATES THAT ALL REGULAR PERFORMANCE TESTS WERE PASSED. HOWEVER, AN ADDITIONAL STATIC TEST ON THE GAS-SIDE OF THE PRODUCT WAS PERFORMED AND DID NOT PASS: ¿THE GAS-SIDE LEAK TEST, ON THE OTHER HAND, WAS NOT PASSED BECAUSE THE PRESSURE DROP IN THE STATIC LEAK TEST COULD NOT MEET THE ACCEPTANCE CRITERIA. A FURTHER EXAMINATION REVEALED THAT THERE WAS A GAS LEAKAGE AT THE GAS FILTER OF THE HLS MODULE.¿ WHILE IT IS POSSIBLE THAT A LEAK AT THE GAS FILTER MAY HAVE CONTRIBUTED TO A LOW PO2, IT IS DIFFICULT TO ASCERTAIN THE EXTENT OF CLINICAL RELEVANCE OF THE PEM FINDING, I.E., GIVEN THAT THE PRESSURE IN THE STATIC TEST IS SIGNIFICANTLY HIGHER (7.5 TO 10 TIMES) COMPARED TO PRESSURE LIKELY EXPERIENCED CLINICALLY (MAXIMUM PERMISSIBLE VALUES FOR HLS SET ADVANCED 5.0 / HIT SET ADVANCED 5.0: PRESSURE ON BLOOD SIDE MAX. 0.533BAR (400MMHG) AND PRESSURE ON GAS SIDE MAX. 12MBAR (9MMHG)). ALSO, DURING CLINICAL PRACTICE, THE GAS-OUTLET(S) ON THE OXYGENATOR ARE UNBLOCKED (UNLIKE THE STATIC TEST THAT WAS PERFORMED), RESULTING IN A LOWER INTRAMEMBRANE PRESSURE (OR BACK-PRESSURE) THAN CREATED IN THE STATIC TEST. IN SUMMARY, THE APPARENT MISMATCH BETWEEN OXYGENATOR SIZE AND THE REQUIRED METABOLIC DEMAND OF THE PATIENT MAY BE THE LIKELY ROOT CAUSE BEHIND THE REPORTED LOW PO2S. FURTHER, AS THE OPERATING CAPACITIES ABOVE SHOWS, THE CUSTOMARY CARDIAC / PERFUSION INDEX USED TO DETERMINE A TARGET BLOOD FLOW (I.E., 2.2 ¿ 2.4 L/MIN/M2) COUPLED WITH THE USE OF THE HLS 5050 WAS LIKELY AN UNDERPOWERED PRODUCT SELECTION RELATIVE TO THE KNOWN PATIENT BSA. THIS FOLLOWS FOR TWO (2) OF THE COMPLAINTS. THE THIRD COMPLAINT (COMPLAINT NUMBER (B)(4)) MAY BE LIKELY RELATED TO A CONFLUENCE OF EXISTING COMORBIDITIES COUPLED WITH CGS, HYPOTENSION, AND LV DYSFUNCTION (WITHOUT KNOWN LV UNLOADING). LAST, NO DETAILS WERE DISCLOSED REGARDING PATIENT BLOOD GASES, VENOUS/ARTERIAL SATURATIONS, OXYGEN DELIVERY/TRANSFER, ETC., SO A DEFINITIVE ROOT CAUSE CANNOT LIKELY BE DETERMINED, BARRING THE DISCLOSURE OF MORE INFORMATION. WHILE THE PEM FINDING IS NOTABLE, THE CONTRIBUTION OF A GAS LEAK TO LOW PO2S CANNOT BE RULED OUT COMPLETELY IN THE ORIGINAL PRODUCTS, AS THE ORIGINAL PRODUCTS INVOLVED COULD NOT BE INVESTIGATED. FURTHER, GIVEN THAT THE PRESSURE IN THE STATIC TEST IS SIGNIFICANTLY HIGHER (7.5 TO 10 TIMES) COMPARED TO PRESSURE LIKELY EXPERIENCED CLINICALLY A CLEAR CONNECTION BETWEEN THE REPORTED EVENT AND A PRODUCT MALFUNCTION, OR DEFICIENCY, IS INCONCLUSIVE. LAST, THE ASSOCIATION BETWEEN EXPIRATION OF THE PATIENT AND THE REPORTED EVENT MAY BE RULED OUT BASED ON THE COMMENTARY FROM THE CUSTOMER IN SUBSEQUENT CORRESPONDENCE AFTER THE ISSUANCE OF THE ORIGINAL COMPLAINTS.¿ ACCORDING TO THE INSTRUCTION OF USE OF THE HLS SET (CHAPTER 2 ¿INTENDED USE¿) IT IS STATED THAT THE HLS SET ADVANCED 5.0 / HIT SET ADVANCED 5.0 CAN BE OPERATED WITH BLOOD FLOWS BETWEEN 0.5 AND 5L/MIN FOR CIRCULATORY SUPPORT. IF BLOOD FLOWS BETWEEN 0.5 AND 7 L/MIN IS NEEDED A HLS SET ADVANCED 7.0 / HIT SET ADVANCED 7.0 SHOULD BE USED. THE AFFECTED PRODUCTS HAVE BEEN REVIEWED ON 2023-10-23. ACCORDING TO THE FINAL TEST RESULTS, THE HLS MODULS PASSED THE TESTS AS PER SPECIFICATIONS. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE 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 CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. H3 OTHER TEXT : HLS SET WAS DISCARDED BY CUSTOMER.

    Description of Event or Problem · 0

    COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLOOD CHANGED COLORS IN BOTH TUBES. THE MONITORING OF THE ARTERIAL AND VENOUS LINE WAS CONTINUED. THE PATIENTS SATURATION WAS BELOW 70% AT 100% FIO2. ADDITIONALLY, THE PO2 VALUES WERE LOW AFTER 24 HOURS OF BEGINNING ECMO FOR ALL THREE PATIENTS. THE POST MEMBRANE SAMPLE WAS SHOWED LOW PO2 VALUES. FOR TWO PATIENTS, THE OXYGENATORS WERE EXCHANGED FOR NEW OXYGENATORS. THE PATIENT IN THIS COMPLAINT EXPIRED. FURTHERMORE, THE EVENTS MENTIONED WILL BE INVESTIGATED IN FOLLOWING COMPLAINTS: (B)(4) AS THREE DIFFERENT PATIENTS HAD THE SAME EVENT AND OUTCOME. ALL AFFECTED HLS SETS WERE DISCARDED BY THE CUSTOMER. COMPLAINT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688407 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BE-HLS 5050 #SHLS SET ADVANCED 5.0 3000261048

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Death