HLS SET
Report
- Report Number
- 8010762-2025-0000537
- Event Type
- Malfunction
- Date Received
- December 3, 2025
- Date of Event
- November 22, 2025
- Report Date
- February 25, 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
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 SPANISH 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 SPAIN DURING TREATMENT. IT WAS REPORTED THAT TWO HLS SETS FROM THE SAME LOT NUMBER (LOT# 3000480980) HAD THE SAME FAULT ON TWO DIFFERENT PATIENTS. THIS COMPLAINT IS ABOUT EVENT TWO. EVENT ONE HAS BEEN INVESTIGATED IN COMPLAINT# (B)(4) AND WAS REPORTED UNDER MFG 8010762-2025-0000536. THE HLS SET WAS CONNECTED TO THE PATIENT ON (B)(6) 2025. THE HLS SET WAS REPLACED ON (B)(6) 2025 AS THE POST-MEMBRANE PARTIAL PRESSURE OF THE OXYGEN WAS BELOW 200 MMHG, DESPITE PERFORMING OXYGEN WASHOUTS BY THE CUSTOMER. THE CUSTOMER STATED THAT THIS VALUE WAS INSUFFICIENT TO OXYGENATE THE PATIENT, AS NORMAL VALUES SHOULD BE ABOVE 400 MMHG. THE PRESSURE READINGS AND THE PATIENT'S ANTICOAGULATION WAS NORMAL. THERE WERE NO TRACES OF FIBRIN OR CLOTS DETECTED. THERE WERE NO FURTHER REPORTED FAILURES WITH THE NEW HLS SET USED (LOT# 3000486609). NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE EXCHANGE OF THE HLS SET DURING USE A REPORT IS REQUIRED. ON 2026-01-19 AN EMAIL HAS BEEN RECEIVED BY THE SPANISH AUTHORITY AEMPS WITH THE FOLLOWING INFORMATION: ¿- INCIDENT DESCRIPTION: CAMBIO DE CIRCUITO. FALLO EN EL OXIGENADOR SIN PRESENCIA DE TROMBOS. - COMMENTS: ESTUDIO RENACER (59-S020). UDI DI (B)(4)¿. THE AFFECTED HLS SET WAS INVESTIGATED IN THE GETINGE LABORATORY ON 2026-02-19: DURING THE INVESTIGATION THE REPORTED FAILURE COULD NOT BE CONFIRMED. A LEAK AND PERFORMANCE TEST WERE PERFORMED AND NO ABNORMALITIES WERE DETECTED THE HLS MODULE IS WORKING ACCORDING TO THE SPECIFICATIONS FROM THE HLS MODULE. DURING THE INVESTIGATION IT WAS DETECTED THAT THE GAS TUBE AND FILTER WAS DISCONNECTED FROM THE HLS MODULE. THIS PREVENTED ANY TESTING OF THE COMPONENTS THAT COULD HAVE INFLUENCED OXYGENATION PERFORMANCE. SPECIFICALLY, REGARDING THE GAS TUBE AND GAS FILTER, IT IS THEREFORE IMPOSSIBLE TO DETERMINE WHETHER THERE WERE ANY DEVIATIONS IN THESE COMPONENTS THAT COULD, FOR EXAMPLE, HAVE AFFECTED THE OXYGEN SUPPLY. THE MISSING GAS TUBE AND FILTER HAS BEEN REQUESTED BY THE SSU ON 2026-02-12 HOWEVER, THE PARTS ARE NOT LONGER AVAILABLE (DISPOSED BY THE CUSTOMER). THEREFORE, NO FURTHER INVESTIGATION IS SCHEDULED. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON 2026-02-18. ACCORDING TO THE FINAL TEST RESULTS, ALL THE MODULES WITH LOT# 3000479874 AND UDI# (B)(4) PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE REVIEW OF SCRAP, REWORK, ENHANCEMENTS, DESIGN CHANGES WERE REVIEWED AND 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. ACCORDING TO THE INSTRUCTIONS FOR USE OF THE HLS SET, IN CHAPTER "SAFETY INSTRUCTIONS FOR THE HLS SET ADVANCED", IT IS STATED THAT " AN INSUFFICIENT SUPPLY OF POWER AND OXYGEN CAN LEAD TO INADEQUATE PATIENT SUPPORT. ENSURE THERE IS A SUFFICIENT SUPPLY OF MEDICAL OXYGEN. ENSURE THAT THE BATTERIES OF THE DRIVE ARE FULLY CHARGED", AS WELL AS "USE A MEDICAL GAS SUPPLY WITH DRY AIR AND OXYGEN. DO NOT USE AN AIR HUMIDIFIER IN THE GAS SUPPLY". IN CHAPTER "SAFETY INSTRUCTIONS FOR THE OXYGENATOR", IT IS INDICATED THAT "EXCEEDING THE PERMISSIBLE MAXIMUM VALUES DAMAGES THE OXYGENATOR. THIS CAN LEAD TO EMBOLISMS AND INADEQUATE PATIENT SUPPORT. OBSERVE THE PERMISSIBLE MAXIMUM VALUES FOR BLOOD FLOW AND GAS FLOW AS WELL AS PRESSURE ON THE BLOOD SIDE AND ON THE GAS SIDE", AS WELL "FLUSH THE OXYGENATOR REGULARLY TO MAINTAIN OR INCREASE THE GAS EXCHANGE CAPACITY. IF USED FOR LONGER THAN 6 HOURS: FLUSH THE OXYGENATOR AT LEAST ONCE A DAY. CARRY OUT FLUSHING ONLY WHEN THE PATIENT'S BLOOD GAS LEVELS PERMIT. MONITOR THE PATIENT'S BLOOD GAS PARAMETERS CAREFULLY DURING THE FLUSHING PROCESS. DISCONTINUE FLUSHING THE GAS FIBERS IF SIGNS OF HYPOCAPNIA OCCUR". LASTLY, IN THE SAME CHAPTER IT IS SAID THAT "THE OXYGENATOR PERFORMANCE IS RESTRICTED IF THE OXYGENATOR OPERATING POSITION IS INCORRECT OR IF THE GAS FLOW IS OBSTRUCTED. THIS CAN LEAD TO INADEQUATE PATIENT SUPPORT OR AIR EMBOLISMS IN THE PATIENT. ONLY OPERATE THE OXYGENATOR WITH THE GAS INLET AT THE TOP. DO NOT OCCLUDE OR BLOCK THE GAS OUTLET". THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND PRODUCT 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. NOTE: THIS EVENT OCCURRED ON THE SPANISH 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 SPAIN DURING TREATMENT. IT WAS REPORTED THAT TWO HLS SETS FROM THE SAME LOT NUMBER (LOT# 3000480980) HAD THE SAME FAULT ON TWO DIFFERENT PATIENTS. THIS COMPLAINT IS ABOUT EVENT TWO ¿ EVENT ONE WILL BE INVESTIGATED IN COMPLAINT# (B)(4). THE HLS SET WAS CONNECTED TO THE PATIENT ON (B)(6) 2025. THE HLS SET WAS REPLACED ON (B)(6) 2025 AS THE POST-MEMBRANE PARTIAL PRESSURE OF THE OXYGEN WAS BELOW 2000 MMHG, DESPITE PERFORMING OXYGEN WASHOUTS BY THE CUSTOMER. THE CUSTOMER STATED THAT THIS VALUE WAS INSUFFICIENT TO OXYGENATE THE PATIENT, AS NORMAL VALUES SHOULD BE ABOVE 400 MMHG. THE PRESSURE READINGS AND THE PATIENTS ANTICOAGULATION WAS NORMAL. THERE WERE NO TRACES OF FIBRIN OR CLOTS DETECTED. THERE WERE NO FURTHER REPORTED FAILURES WITH THE NEW HLS SET USED (LOT# 3000486609). THE HLS SET WAS AVAILABLE FOR INVESTIGATION. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE EXCHANGE OF THE HLS SET DURING USE A REPORT IS REQUIRED COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142670 | HLS SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | BE-HLS 7050 #SHLS SET ADVANCED 7.0 | 3000480980 | 04058863005744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Required Intervention |