HLS SET
Report
- Report Number
- 8010762-2025-0000247
- Event Type
- Malfunction
- Date Received
- June 16, 2025
- Date of Event
- June 10, 2025
- Report Date
- September 5, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- UDI-DI
- 04058863080383
- PMA / PMN Number
- K112360
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- 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: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THE LOT NUMBER OF THE AFFECTED SET WAS NOT PROVIDED. THEREFORE IT IS NOT POSSIBLE TO IDENTIFY THE SET LOT NUMBER OF THE DEVICE IN QUESTION AND THEREFORE ITS UDI NUMBER.
THE EVENT OCCURRED IN THE US. IT WAS REPORTED THAT THIS COMPLAINT IS RELATED WITH THE CARDIOHELP COMPLAINT OT 1306274 OS: 793502. THE CUSTOMER WAS "UNABLE TO HAND CRANK THE HLS SET" (USE THE EMERGENCY DRIVE) DURING THE HARDWARE ISSUE (SEE COMPLAINT 1306274 REPORTED UNDER MFG# 8010762-2025-0000252), HOWEVER, IT WAS UNCLEAR WHY THEY WERE UNABLE TO DO SO. THE HLS SET WAS REPLACED, DUE TO SUSPECTED CLOTS, WITH A NEW ONE DURING USE WITHOUT CONSEQUENCES FOR THE PATIENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. FURTHER INFORMATION HAS BEEN PROVIDED FROM THE SSU (SALES AND SERVICE UNIT) AS FOLLOWS: ANTICOAGULATION WAS NOT BEING USED AT THE TIME OF THE INCIDENT DUE TO RISK OF BLEEDING COMPLICATIONS. ACCORDING TO THE CUSTOMER THE CIRCUIT AFTER REMOVAL FROM THE PATIENT, CLOTS AND FIBRIN WERE VISIBLE ON INLET SIDE OF THE OXYGENATOR. THE PATIENT HAD RECEIVED HEPARIN DURING CANNULATION BUT DID NOT RECEIVE A CONTINUOUS INFUSION. DUE TO REPORTED EXCHANGE OF THE PRODUCT DURING USE A REPORT IS REQUIRED. THE INVOLVED CARDIOHELP-I DEVICE WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN AND NO MALFUNCTION COULD BE REPLICATED AND NO PARTS WERE REPLACED. THE AFFECTED PRODUCT WAS INVESTIGATED BY THE GETINGE LABORATORY ON 2025-08-25 WITH FOLLOWING CONCLUSION: A VISUAL INSPECTION AND A PERFORMANCE TEST WAS PERFORMED AND NO DEVIATIONS OR LEAKAGE WERE DETECTED. HOWEVER, IT WAS DISCOVERED THAT A LARGE AMOUNT OF BIOLOGICAL MATERIAL WAS PRESENT IN THE PRODUCT¿PARTICULARLY IN THE BLOOD INLET CHANNEL AND IN THE PUMP MODULE ON THE ROTOR ASSEMBLY. A MEDICAL CONSULTATION WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON 2025-09-04 WITH FOLLOWING CONCLUSION: "THE RESULT OF THE HLS SET INSPECTION APPEARED TO SHOW THAT THE PRODUCT PERFORMED AS EXPECTED AND DESIGNED (SAVE LEAKAGE FROM A PRESSURE SENSOR LOCATION WHICH WAS NOT REPORTED IN THE COMPLAINT). ADDITIONALLY, THE TAPE (PROTECTIVE FILM) COVERING THE SUPERIOR ASPECT OF THE ROTOR SHROUD WAS MISSING (PHOTO BELOW) WHICH SUGGESTS THAT THE CUSTOMER HAS THE HLS MODULE PROPERLY SEATED IN THE ER DRIVE WHICH PERFORATES THE FILM COVERING THE SUPERIOR SLOT. HARDWARE INSPECTION RESULTS ARE AS FOLLOWS: THE INSPECTION OF THE HARDWARE RULED OUT ANY MALFUNCTION OF THE HAND CRANK (ER DRIVE). FINAL ASSESSMENT: THE FOLLOWING SEEMS TO BE REASONABLY RULED OUT: - MALFUNCTION OF THE ER DRIVE (HANDCRANK). IT IS ASSUMED FROM THE COMPLAINT NARRATIVE THAT THE DESCRIPTION OF INABILITY TO USE THE HAND CRANK WAS INTENDED AS AN INABILITY TO ACHIEVE BLOOD FLOW. - FAULTY SEATING OF THE HLS MODULE IN THE ER DRIVE. IT IS ASSUMED THAT IF THE SUPERIOR SLOT TAPE WAS PERFORATED AND THE INFERIOR SLOT WAS UNDAMAGED THAT THE HLS MODULE WAS PROPERLY SEATED IN THE ER DRIVE. - DEFECT IN THE HLS PRODUCT. THIS WAS BORNE OUT IN THE INSPECTION OF THE HLS SET ADVANCED. THERE WAS MENTION OF THROMBUS IN THE PUMP ASPECT OF THE HLS MODULE IN RESPONSE TO THE QUESTIONS SUBMITTED TO THE CUSTOMER. THE ABSENCE OF ANTICOAGULATION (AS A CONCERN FOR BLEEDING) COUPLED WITH THE REPORT BY THE CUSTOMER THROMBUS PRESENT IN THE HLS MODULE SEEMS TO LAY THE GROUNDWORK FOR THROMBUS INHIBITING THE PROPER FUNCTION THE PUMP ROTOR AS A REASONABLE AND PROBABLE ROOT CAUSE OF THE EVENT REPORTED BY THE CUSTOMER. IT SHOULD BE NOTED THAT WHILE THROMBUS WAS OBSERVED IN THE PRODUCT EXAMINED BY GETINGE, THROMBUS MAY HAVE FORMED OVER TIME AS THE PRODUCT WAS SHIPPED TO GETINGE FOR EXAMINATION." BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED, BUT NO PRODUCT RELATED MALFUNCTION. THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON 2025-09-01. ACCORDING TO THE FINAL TEST RESULTS, ALL THE MODULES WITH LOT# 3000432423 AND UDI# (B)(4) PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE REVIEW OF SCRAP, REWORK, ENHANCEMENTS AND DESIGN CHANGES WERE REVIEWED AN 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 PRODUCT AND FAILURE. ACCORDING TO THE INSTRUCTION OF USE OF THE HLS SET IN CHAPTER "SAFETY INSTRUCTIONS FOR THE EXTRACORPOREAL CIRCULATION" IT IS STATED THAT NO ANTICOAGULATION OR INSUFFICIENT ANTICOAGULATION CAUSES OCCLUSION OF THE EXTRACORPOREAL CIRCULATION AND THE PATIENT CIRCUIT. THIS CAN LEAD TO INADEQUATE PATIENT SUPPORT, HEMOLYSIS OR THROMBUS FORMATION IN THE PATIENT. IT IS RECOMMENDED TO USE ANTICOAGULANTS; E.G. HEPARIN OR ARGATROBAN AND TO CHECK THE EFFECT OF ANTICOAGULANTS AT REGULAR INTERVALS BY MEASURING THE ACT (ACTIVATED CLOTTING TIME). ENSURE THAT THE ACT VALUE DOES NOT FALL BELOW THE VALUE WHICH IS APPROPRIATE FOR THE APPLICATION. FURTHER THE COAGULATION STATUS OF THE PATIENT'S BLOOD SHOULD BE CHECKED REGULARLY. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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.
THE EVENT OCCURRED IN THE US. THE CUSTOMER WAS "UNABLE TO HAND CRANK THE HLS SET" (USE THE EMERGENCY DRIVE) DURING AN ISSUE WITH THE CARDIOHELP MACHINE (COMPLAINT ID (B)(4), HOWEVER, IT WAS UNCLEAR WHY THEY WERE UNABLE TO DO SO. THE HLS SET WAS REPLACED, DUE TO SUSPECTED CLOTS, WITH A NEW ONE DURING USE WITHOUT CONSEQUENCES FOR THE PATIENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO REPORTED EXCHANGE OF THE PRODUCT 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 |
|---|---|---|---|---|---|---|---|
| 916200 | HLS SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | 701069078 | 3000437922 | 04058863080383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Required Intervention |