TUBING SET
Report
- Report Number
- 8010762-2025-0000522
- Event Type
- Malfunction
- Date Received
- November 26, 2025
- Date of Event
- November 18, 2025
- Report Date
- February 19, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- UDI-DI
- 04058863300238
- PMA / PMN Number
- K112360
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE CANADIAN 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: 701069065.
THE EVENT OCCURRED IN CANADA DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE HLS SET WAS LEAKING BLOOD. THE LEAKAGE WAS LOCATED AT THE GAS OUTLET. THE ECMO PROCEDURE STARTED ON (B)(6) 2025 AND THE LEAKAGE WAS OBSERVED ON (B)(6) 2025. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS NOT AFFECTED BY THE REPORTED LEAKAGE. NO ABNORMALITIES WERE OBSERVED DURING PRIMING OF THE HLS SET. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE INVOLVED PATIENTS INDICATION FOR ECMO WAS THE FOLLOWING: "POST MVR/CABX3, AV GROVE DISRUPTION REPAIR, BLEEDING, HEMODYNAMIC INSTABILITY". AS THERE WAS A LEAKAGE DURING PATIENT TREATMENT, A REPORT IS REQUIRED. THE EXACT ROOT CAUSE REMAINS UNKNOWN, AS THE PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION AS IT WAS SCRAPPED BY THE CUSTOMER. HOWEVER, A MEDICAL CONSULTATION WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON 2026-02-10 WITH FOLLOWING CONCLUSION: "PROBABLE ROOT CAUSE(S): BASED ON THE AVAILABLE INFORMATION, POTENTIAL ROOT CAUSES FOR THE LEAKAGE AT THE GAS-OUTLET OF THE HLS SET MAY INCLUDE: 1) MANUFACTURING DEFECT: A POSSIBLE CAUSE INCLUDES A DEFECT IN THE HLS-MODULE (E.G., MICROCRACK, INCOMPLETE BONDING, DIMENSIONAL DEVIATION, FIBER RUPTURE, ETC.). 2) DAMAGE DURING SHIPPING/ UNPACKING OR SETUP: ACCIDENTAL IMPACT DURING UNPACKING OR INSTALLATION COULD HAVE INTRODUCED A DEFECT OR WORSENED AN EXISTING DEFECT. 3) DAMAGE DURING TRANSPORT: NO MENTION PATIENT TRANSPORT IS CITED IN THE COMPLAINT NARRATIVE. HOWEVER, THE FOLLOWING PHOTOS SUGGEST THAT THE CARDIOHELP SYSTEM WAS PLACED ONE OF THE DEVICE SIDES TO CREATE A BLOOD PATTERN FROM BACK TOWARDS FRONT OF THE MACHINE. THEREFORE, IT MAY ASSUMED THE SOME FORM OF TRANSPORT OR DEVICE POSITIONING MAY HAVE TAKEN PLACE. FURTHER, IT IS UNKNOWN IF TRANSPORT MAY HAVE INFLUENCED THE REPORTED EVENT. POTENTIAL RISKS TO PATIENT: 1) AIR EMBOLISM: A LEAK AT THE GAS OUTLET, PARTICULARLY UNDER NEGATIVE PRESSURE, CAN INTRODUCE AIR INTO THE CIRCUIT, WHICH POSES A SERIOUS AND POTENTIALLY FATAL RISK. AS A NOTE, NEGATIVE MAY BE OBSERVED DURING A PUMP STOP WHEN THE CARDIOHELP/HLS UNIT IS LOCATED HIGHER THAN THE LEVEL OF THE PATIENT¿S HEART. 2) BLOOD LOSS: DEPENDING ON THE SIZE AND LOCATION OF THE LEAK, THERE MAY BE A RISK OF BLOOD LOSS OR CIRCUIT FLOW INSTABILITY, WHICH COULD COMPROMISE OXYGENATION OR PERFUSION. IN THIS CASE, ACCORDING TO THE CUSTOMER¿S REPORT, THE BLOOD LOSS WAS APPROXIMATELY 100 - 200 ML. THE CUSTOMER MENTIONED THE NEED FOR BLOOD TRANSFUSION; HOWEVER, BASED ON THE INFORMATION PROVIDED, THE TRANSFUSION WAS NOT REQUIRED SOLELY DUE TO THE LEAKAGE OF THE HLS SET. FURTHERMORE, AS LATER CONFIRMED BY THE USER, NO BLOOD PRODUCTS WERE REQUIRED DURING ECMO TREATMENT. ALL BLOOD COMPONENTS ADMINISTERED WERE GIVEN DURING THE SURGICAL PROCEDURE AND WHILE THE PATIENT WAS ON CARDIOPULMONARY BYPASS. 3) INFECTION: THE LEAKAGE OF THE HLS-SET DOES NOT ENSURE LONG-TERM STERILITY OR MECHANICAL SECURITY, INCREASING INFECTION OR FAILURE RISK IF LEFT IN PLACE. 4) CIRCUIT COMPROMISE RESULTING IN HEMODYNAMIC INSTABILITY SECONDARY TO EMERGENT PRODUCT EXCHANGE: CONTINUED USE OF A COMPROMISED ECMO SET, EVEN TEMPORARILY, MAY PRESENTS A RISK OF UNEXPECTED DISCONNECTION OR WORSENING OF A NONCONFORMANCE OR DEFECT UNDER PRESSURE. FURTHER, AN EXCHANGE OF THE PRODUCT DURING SUPPORT MAY BE NECESSARY (AS WITH THIS COMPLAINT) WITH CONTINUED USE, I.E., IF THE NONCONFORMANCE EXACERBATES. THE REPORTED LEAKAGE AT THE GAS OUTLET MAY HAVE NECESSITATED A COMPLETE EXCHANGE OF THE EXTRACORPOREAL CIRCUIT DEPENDING ON THE CLINICAL CIRCUMSTANCES SURROUNDING EXTRACORPOREAL SUPPORT AND THE CLINICAL DECISION TREE. THAT SAID, THE CLINICAL DECISION NOT TO REPLACE THE MALFUNCTIONING HLS SET WAS NOT CLARIFIED BY THE CLIENT. AS THE HLS SET IN USE MAY HAVE REQUIRED REPLACEMENT, A SYSTEM CHANGE MAY HAVE POSED ADDITIONAL POTENTIAL RISKS TO THE PATIENT, INCLUDING BLOOD LOSS, HEMODYNAMIC INSTABILITY, AND IMPAIRED OXYGENATION. THE BLOOD LOSS ASSOCIATED WITH THE LEAK WAS REPORTED AS MILD (APPROXIMATELY 100 - 200 ML). THE PATIENT SURVIVED THE EVENT; THEREFORE, A DIRECT CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE PATIENT¿S CLINICAL OUTCOME CANNOT BE ESTABLISHED. THE AFOREMENTIONED RISKS ARE CONSIDERED POTENTIAL RISKS ASSOCIATED WITH EITHER CONTINUED USE OF THE PRODUCT OR A PRODUCT EXCHANGE. LAST, A PROPOSED (OR DEFINITIVE) ROOT CAUSE CANNOT BE EXPLORED VIA INVESTIGATION OF THE PRODUCT DUE TO DISPOSAL OF THE PRODUCT. THAT SAID, THE REPORTED BLOOD LOSS DID NOT APPEAR TO RESULT IN THE ADMINISTRATION OF BLOOD PRODUCTS ACCORDING TO CORRESPONDENCE WITH THE CUSTOMER." THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON 2026-01-07. ACCORDING TO THE FINAL TEST RESULTS, THE PRODUCT PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE REVIEW OF SCRAP, REWORK, ENHANCEMENTS AND DESIGN CHANGES WERE REVIEWED AND NO ABNORMALITIES IN REGARDS 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 REGARDS TO THE REPORTED FAILURE. AS STATED IN THE INSTRUCTIONS FOR USE HLS SET ADVANCED 5.0 / 7.0, HIT SET ADVANCED 5.0 / 7.0 - IN CHAPTER PREPARATION AND INSTALLATION ¿PERFORM A CAREFUL VISUAL INSPECTION OF THE DEVICE BEFORE USE. IN PARTICULAR, ENSURE THERE IS NO DAMAGE TO THE MATERIAL, CRACKS, BURRS OR FISSURES.¿ FURTHERMORE, IT IS STATED IN CHAPTER PRIMING THE SYSTEM ¿CHECK THE DEVICE FOR LEAKS DURING PRIMING. DO NOT USE THE DEVICE IF THERE ARE ANY LEAKS.¿ AND ¿BEFORE PRIMING THE SET, RUN WATER THROUGH THE HEAT EXCHANGER OF THE HLS MODULE ADVANCED AND CHECK FOR LEAKS.¿ BASED ON THE PHOTOGRAPHIC EVIDENCE PROVIDED FROM THE CUSTOMER THE REPORTED FAILURE "LEAKAGE AT GAS OUTLET" COULD BE CONFIRMED. 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. NOTE: THIS EVENT OCCURRED ON THE CANADIAN 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 701069065.
NEW INFORMATION HAS BEEN RECEIVED. NO LEAKAGE WAS DISCOVERED DURING PRIMING PROCEDURE. THE HLS SET WAS NOT REPLACED DURING THE TREATMENT. THE INVOLVED PATIENT HAD A BLOOD LOSS OF ABOUT 100-200 ML. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE AFFECTED HLS SET WAS NOT AVAILABLE FOR INVESTIGATION. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE CANADIAN 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 701069065.
THE EVENT OCCURRED IN CANADA DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE HLS SET WAS LEAKING BLOOD. THE LEAKAGE WAS LOCATED AT THE GAS OUTLET. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THERE WAS A LEAKAGE DURING PATIENT TREATMENT, A REPORT IS REQUIRED. COMPLAINT ID#: (B)(4).
COMPLAINT ID# (B)(4).
COMPLAINT ID #: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2538497 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET | 3000438773 | 04058863300238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |