HLS SET
Report
- Report Number
- 8010762-2025-0000362
- Event Type
- Death
- Date Received
- August 18, 2025
- Date of Event
- July 30, 2025
- Report Date
- January 13, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- UDI-DI
- 04058863005744
- PMA / PMN Number
- K112360
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NEW INFORMATION WAS RECEIVED ON 2025-11-10 FROM THE GETINGE SALES AND SERVICE UNIT (SSU). THE CUSTOMER CONFIRMED TO THE SSU THAT THE SECOND USED HLS SET, WHICH WAS CONNECTED TO THE PATIENT AT THE TIME OF PASSING, IS NOT AVAILABLE FOR INVESTIGATION. THE CUSTOMER ALSO CONFIRMED, THAT THERE WAS NO MALFUNCTION WITH THIS SECOND USED HLS SET. THE PRESSURES HAD NORMALIZED AFTER REPLACING THE FIRST USED HLS SET. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE COLOMBIAN MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "HLS SET¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K112360. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR HLS SET WITH CATALOG NUMBER 701069073.
NEW INFORMATION REGARDING THE INVOLVED PATIENT WAS RECEIVED ON 2025-09-07 FROM THE GETINGE SALES AND SERVICE UNIT (SSU). THE CUSTOMER CONFIRMED TO THE SSU THAT THE PATIENT PASSED AWAY DAYS AFTER THE REPORTED EVENT DUE TO HIS CLINICAL CONDITION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE COLOMBIAN MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "HLS SET¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K112360. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR HLS SET WITH CATALOG NUMBER 701069073.
THE EVENT OCCURRED IN COLOMBIA. IT WAS REPORTED THAT A PATIENT IN CARDIOGENIC SHOCK WITH REFRACTORY HYPOXEMIA, PAFI OF 70 WITH DUAL INOTROPIC SUPPORT, WITH ECHO SHOWING SEVERE DILATION OF THE RIGHT CAVITIES, UNDER GENERAL ANESTHESIA, ECMO RESCUE IS STARTED IN HEMODYNAMIC ROOMS UNDER FLUOROSCOPY, RIGHT FEMORAL PUNCTURE IS PERFORMED BY INTERVENTIONAL RADIOLOGY ADVANCING GUIDE THROUGH THE INFERIOR VENA CAVA TO THE RETROHEPATIC CAVA AND A LIVANOVA 23-25 DUAL STAGE CANNULA IS PASSED UP TO 65CM, THEY PROCEED TO PERFORM JUGULAR PUNCTURE AND PASS GUIDE AND SUBSEQUENT LIVANOVA 23-25 CANNULA AND IT IS POSITIONED IN THE PULMONARY ARTERY, IN PARALLEL, CARDIOHELP SYSTEM PURGE IS PERFORMED WITH HLS 7.0, VENOVENO-PULMONARY ARTERY ECMO THERAPY IS STARTED AT 1:40 P.M., WITH 3.5 LITERS OF FLOW, WITH RPM 3195 VENOUS SATURATION 70%, PVEN -92, PART 126 PINT 172, DELTA 46, PROGRESSIVELY AN INCREASE IN DELTA IS OBSERVED UP TO 153 AT 14:30, AND FLOW DROP 2.47 WITH RPM 3255 PVEN -26 PART 19 PINT 262, VENOUS SATURATION DROP 59%, ACT POST ECMO 200, PATIENT PREVIOUSLY ANTICOAGULATED WITH HEPARIN INFUSION 100UND/H, CUSTOMER DECIDED TO CHANGE THE CIRCUIT. A NEW HLS SET WAS USED AND STARTED WITH ECMO FLOW PARAMETERS 3.6 WITH RPM 3000, PVEN -64, PART 140, PINT 169 DELTA 29. ON 2025-09-07, NEW INFORMATION REGARDING THE INVOLVED PATIENT WAS RECEIVED FROM THE GETINGE SALES AND SERVICE UNIT (SSU). THE CUSTOMER CONFIRMED TO THE SSU THAT THE PATIENT PASSED AWAY DAYS AFTER THE REPORTED EVENT DUE TO HIS CLINICAL CONDITION. FURTHERMORE ON 2025-11-10, ADDITIONAL INFORMATION FROM THE GETINGE SALES AND SERVICE UNIT (SSU) HAS BEEN PROVIDED AS FOLLOWS. THE CUSTOMER CONFIRMED TO THE SSU THAT THE SECOND USED HLS SET, WHICH WAS CONNECTED TO THE PATIENT AT THE TIME OF PASSING, IS NOT AVAILABLE FOR INVESTIGATION. THE CUSTOMER ALSO CONFIRMED THAT THERE WAS NO MALFUNCTION WITH THIS SECOND USED HLS SET. THE PRESSURES HAD NORMALIZED AFTER REPLACING THE FIRST USED HLS SET. DUE TO THE EXCHANGE OF THE HLS SET DURING USE WITH A NEW ONE A REPORT IS REQUIRED. THE PATIENT PASSED AWAY DAYS AFTER THE REPORTED EVENT DUE TO HIS CLINICAL CONDITION. THE AFFECTED HLS SET IS NOT AVAILABLE FOR TECHNICAL INVESTIGATION AS THE HLS SET WAS DISCARDED BY THE CUSTOMER. THEREFORE, THE EXACT ROOT CAUSE REMAINS UNKNOWN. A MEDICAL REVIEW WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON 2025-12-22 WITH FOLLOWING CONCLUSION: "ACCORDING TO THE INFORMATION PROVIDED IN THE COMPLAINT REPORT, WHICH WAS CONFIRMED BY THE CUSTOMER QUESTIONNAIRE, THE PATIENT WAS IN A CRITICAL CONDITION WITH CARDIOGENIC SHOCK, REFRACTORY HYPOXEMIA, AND MULTIPLE COMORBIDITIES INCLUDING HEART FAILURE, ATRIAL FIBRILLATION, PULMONARY EMBOLISM, ARTERIAL HYPERTENSION, AND OBESITY. THE CUSTOMER DESCRIBED THE INITIATION OF ECMO AS A ¿RESCUE ECMO¿ PROCEDURE. BASED ON CONTEXT, THE INTERPRETATION/ASSUMPTION IS THAT SUPPORT WAS INITIATED EMERGENTLY AS AN INTERVENTION INTENDED TO PROVIDE LIFE-SUSTAINING SUPPORT IN AN ACUTE SITUATION. DURING ECMO THERAPY, A PROGRESSIVE INCREASE IN TRANSMEMBRANE PRESSURE GRADIENT AND A DECREASE IN BLOOD FLOW WERE OBSERVED IN THE FIRST HLS SET. THESE DETAILS ARE DOCUMENTED IN THE COMPLAINT REPORT AND CONFIRMED BY THE CUSTOMER. THE TRANSMEMBRANE PRESSURE GRADIENT GREW FROM 46 MMHG TO 153 MMHG, AND FLOW DROPPED FROM 3.5 L/MIN TO 2.47 L/MIN DESPITE RPM ADJUSTMENTS. ACCORDING TO THE CUSTOMER STATEMENT, NO CLOTS, LEAKS, OR VISIBLE ABNORMALITIES WERE OBSERVED IN THE FIRST HLS SET, AND ANTICOAGULATION WAS ADMINISTERED AS DESCRIBED. AFTER REPLACING THE HLS SET AND RESTARTING THERAPY, PRESSURES NORMALIZED AND FLOW RETURNED TO EXPECTED VALUES, WHICH INDICATES THAT THE ISSUE WAS ISOLATED TO THE FIRST SET. THE AFFECTED PRODUCT WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, A POSSIBLE ROOT CAN NEITHER BE CONCLUSIVELY DETERMINED NOR PROPOSED. BASED ON THE AVAILABLE INFORMATION, A REASONABLE AND POSSIBLE ROOT CAUSE FOR THE INCREASE IN TRANSMEMBRANE PRESSURE GRADIENT MAY BEEN EITHER CLOT FORMATION OR ASPIRATION INTO THE CIRCUIT WHICH MAY HAVE LED TO AN OBSTRUCTION OF THE MEMBRANE. THE COMPLAINT NARRATIVE SPEAKS TO A PULMONARY EMBOLISM AS ONE OF THE FACTORS CONTRIBUTING TO THE DECISION TO INITIATE EXTRACORPOREAL SUPPORT. THAT SAID, PULMONARY EMBOLI ARE CONSIDERED AS ORIGINATING FROM DEEP VEIN (VIZ, LEGS AND PELVIS) THROMBOSIS (DVT) WHICH MAY HAVE PROVIDED A SOURCE FOR ASPIRATION OF THROMBUS INTO THE EXTRACORPOREAL CIRCUIT WHICH WAS PASSED TO THE HLS MODULE. FURTHER, THE COMPLAINT NARRATIVE STATES THAT THE PATIENT UNDERWENT THROMBOLYSIS WHICH PROVED UNSUCCESSFUL. DELIVERY OF THROMBUS TO THE MEMBRANE WOULD HAVE MANIFESTED AS AN INCREASE IN DELTA P AND A REDUCTION OF GAS TRANSFER (DEPENDING ON SIZE OF INVOLVEMENT). LAST, A THROMBUS MAY HAVE BEEN OBSTRUCTED FROM VIEW TO THE OPERATOR, I.E., DEPENDING ON THE FINAL LANDING LOCATION (E.G., CENTER OF THE PRE-MEMBRANE FACE OR MIDDLE OF THE MEMBRANE PACKAGE). IF THE PATIENT WERE SUBJECT TO DVT AS THE SOURCE OF A PULMONARY EMBOLISM, IT IS LIKELY THAT AN UNDERLYING COAGULOPATHY OR PREDISPOSING RISK FACTORS WERE PRESENT. THE PATIENT PASSED AWAY DAYS AFTER THE EVENT. ACCORDING TO THE CUSTOMER STATEMENT, THE DEATH WAS DUE TO THE UNDERLYING CLINICAL CONDITION OF THE PATIENT, NOT RELATED TO THE REPORTED EVENT. THERE IS NO INDICATION OF A DIRECT CAUSAL RELATIONSHIP BETWEEN THE DEVICE MALFUNCTION AND THE EXPIRATION OF THE PATIENT DESPITE A PRODUCT EXCHANGE. THE REPORTED EVENT RESULTED IN A DROP IN VENOUS SATURATION, A DECREASE IN PO2, AN INCREASE IN PCO2 WHICH ARE INDICATIVE OF A REDUCTION IN MEMBRANE AREA. THAT SAID, THE REPORTED EVENT APPEARS TO HAVE BEEN MITIGATED (AND CORRECTED) BY REPLACEMENT OF THE HLS SET. THAT SAID, A CONCLUSIVE DETERMINATION OF MEMBRANE PERFORMANCE WOULD HAVE BENEFITTED FROM DIRECT INVESTIGATION OF THE PRODUCT. NO USE ERROR WAS IDENTIFIED. GIVEN THE DETAILS OFFERED BY THE CUSTOMER IN THE COMPLAINT NARRATIVE, CORRESPONDENCE, AND QUESTIONNAIRE, PATIENT OUTCOME CANNOT BE DEFINITIVELY ATTRIBUTED TO A DEVICE DEFECT/MALFUNCTION OR REDUCTION IN PERFORMANCE (I.E., BARRING DIRECT EVALUATION OF THE DEVICE)." BASED ON THE PROVIDED PICTURE BY THE CUSTOMER THE REPORTED FAILURE "DELTA P INCREASED" COULD BE CONFIRMED BUT IS NOT RELATED TO THE PATIENT`S DEATH. THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON 2026-01-09. ACCORDING TO THE FINAL TEST RESULTS, THE MODULES WITH LOT#: 3000446962 PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE REVIEW OF SCRAP, REWORK, ENHANCEMENTS, DESIGN CHANGES WERE REVIEWED AN NO ABNORMALITIES IN REGARD TO THE REPORTED FAILURE WERE FOUND. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED FOR THE REVIEWED TIME PERIOD. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. REFERRING TO THE INSTRUCTION FOR USE (HLS SET ADVANCED 5.0 / 7.0, HIT SET ADVANCED 5.0 / 7.0 CHAPTER PREPARATION AND INSTALLATION) THE PRESSURE SENSORS HAVE TO BE CHECKED BEFORE PRIMING. FURTHER THE CARDIOHELP HAS A FLOW/BUBBLE SENSOR AND A VENOUS PROBE TO MEASURE AND CONTROL THE BLOOD FLOW AND PARAMETERS. IF THE MEASURED VALUES ARE ABOVE HIGH LIMIT OR BELOW LOW LIMIT OF THE SET LIMITS THE SYSTEM GENERATES A VISUAL AND ACOUSTICAL ALARM. 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.
THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE COLOMBIAN MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "HLS SET¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K112360. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR HLS SET WITH CATALOG NUMBER 701069073.
COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
THE EVENT OCCURRED IN COLOMBIA. IT WAS REPORTED THAT A PATIENT IN CARDIOGENIC SHOCK WITH REFRACTORY HYPOXEMIA, PAFI OF 70 WITH DUAL INOTROPIC SUPPORT, WITH ECHO SHOWING SEVERE DILATION OF THE RIGHT CAVITIES, UNDER GENERAL ANESTHESIA, ECMO RESCUE IS STARTED IN HEMODYNAMIC ROOMS UNDER FLUOROSCOPY, RIGHT FEMORAL PUNCTURE IS PERFORMED BY INTERVENTIONAL RADIOLOGY ADVANCING GUIDE THROUGH THE INFERIOR VENA CAVA TO THE RETROHEPATIC CAVA AND A LIVANOVA 23-25 DUAL STAGE CANNULA IS PASSED UP TO 65CM, THEY PROCEED TO PERFORM JUGULAR PUNCTURE AND PASS GUIDE AND SUBSEQUENT LIVANOVA 23-25 CANNULA AND IT IS POSITIONED IN THE PULMONARY ARTERY, IN PARALLEL, CARDIOHELP SYSTEM PURGE IS PERFORMED WITH HLS 7.0, VENOVENO-PULMONARY ARTERY ECMO THERAPY IS STARTED AT 1:40 P.M., WITH 3.5 LITERS OF FLOW, WITH RPM 3195 VENOUS SATURATION 70%, PVEN -92, PART 126 PINT 172, DELTA 46, PROGRESSIVELY AN INCREASE IN DELTA IS OBSERVED UP TO 153 AT 14:30, AND FLOW DROP 2.47 WITH RPM 3255 PVEN -26 PART 19 PINT 262, VENOUS SATURATION DROP 59%, ACT POST ECMO 200, PATIENT PREVIOUSLY ANTICOAGULATED WITH HEPARIN INFUSION 100UND/H, CUSTOMER DECIDED TO CHANGE THE CIRCUIT. A NEW HLS SET WAS USED AND STARTED WITH ECMO FLOW PARAMETERS 3.6 WITH RPM 3000, PVEN -64, PART 140, PINT 169 DELTA 29. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE EXCHANGE OF THE HLS DURING USE WITH A NEW ONE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1542588 | HLS SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | BE-HLS 7050 #SHLS SET ADVANCED 7.0 | 3000452354 | 04058863005744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Required Intervention| D |