TUBING SET
Report
- Report Number
- 8010762-2025-0000072
- Event Type
- Malfunction
- Date Received
- February 20, 2025
- Date of Event
- February 13, 2025
- Report Date
- April 29, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- UDI-DI
- 04058863078298
- PMA / PMN Number
- K112360
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 SAUDI ARABIA DURING TREATMENT. IT WAS REPORTED THAT A PATIENT WAS ON ECMO WITH ADDITIONALLY AN IMPELLA PUMP. ALL OF THE SUDDEN THE CARDIOHELP STARTED TO DISPLAY ¿PUMP DISPOSABLE ERROR STOP¿ AND THE FLOW CAME DOWN TO ZERO. THE CUSTOMER IMMEDIATELY CHECKED THE HLS SET, TUBINGS AND CANNULAS FOR ANY POSSIBLE KINK OR LEAK OR ANY VISIBLE DAMAGE. AFTER NO DAMAGE OR OBSTRUCTION WAS FOUND, THE PATIENT WAS HAND CRANKED WHEN THE HLS SET WAS REMOVED FROM THE CARDIOHELP DEVICE. THE ISSUE REMAINS, NO FLOW COULD BE ACHIEVED DURING HAND CRANKING ON THE HLS SET. THE CARDIOHELP AND HLS SET WERE REPLACED. NO HARM TO ANY PERSON HAS BEEN REPORTED. NEW INFORMATION RECEIVED ON 2025-02-19 THAT THE FAILURE OCCURRED ON DAY ONE OF TREATMENT. THERE WERE NO VISIBLE CLOTS IN THE SYSTEM. THE CUSTOMER CONFIRMED THAT THERE WAS NO FAULT WITH THE CARDIOHELP DEVICE. A GETINGE SERVICE TECHNICIAN INVESTIGATED THE CARDIOHELP DEVICE AND COULD NOT DUPLICATE ANY ERROR. THE DEVICE IS FUNCTIONING AS EXPECTED. AS THERE WAS A PUMP STOP DURING TREATMENT, AND A NO FLOW SITUATION FOR THE PATIENT. AS WELL AS THE HLS SET WAS REPLACED, A REPORT IS REQUIRED. THE PATIENT DATA WAS NOT SHARED BY CUSTOMER. THE AFFECTED HLS SET WAS INVESTIGATED IN THE GETINGE LABORATORY ON 2025-04-29 WITH FOLLOWING CONCLUSION: THE FAILURE COULD NOT BE CONFIRMED. NO DEVIATIONS OR ANY MALFUNCTION ON THE HLS MODULE COULD BE DETECTED DURING THE INVESTIGATION. THE HLS MODULE WAS WORKING AS INTENDED. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE "PUMP DISPOSABLE ERROR" COULD NOT BE CONFIRMED. HOWEVER, ACCORDING TO THE RISK ASSESSMENT OF THE HLS SET (DMS 1468452, V27), THE FOLLOWING ROOT CAUSES CAN LEAD TO THE REPORTED FAILURE: - STATIC LOAD OF THE OXYGENATOR - LOOSENING / DIS-MANTLING OF THE PUMP. THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE REVIEWED ON 2025-04-29. ACCORDING TO THE FINAL TEST RESULTS, THE MODUL WITH LOT# 3000370006 AND UDI# 1788242 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 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. AS STATED IN THE INSTRUCTION FOR USE OF THE CARDIOHELP - CHAPTER "CHECK BEFORE EVERY APPLICATION": ¿BEFORE APPLICATION, ENSURE THAT THE CARDIOHELP-I IS SECURELY FIXED AND CORRECTLY INSTALLED AND THAT IT IS NECESSARY TO DECREASE THE FLOW TO ZERO BEFORE DISCONNECTING AND CONNECTING THE DISPOSABLE TO THE DEVICE." FURTHER IN THE INSTRUCTIONS FOR USE OF THE HLS SET, IT IS SAID IN CHAPTER "SAFETY INSTRUCTIONS FOR THE OXYGENATOR" THAT "INCORRECT INSTALLATION OF THE HLS MODULE ADVANCED CAN LEAD TO DEVICE MALFUNCTION. ENSURE THAT THE DEVICE IS FITTED ONTO THE DEVICE CORRECTLY AND SECURELY FIXED, TO ELIMINATE THE RISK OF MAGNETIC DECOUPLING BETWEEN THE DRIVE AND THE CENTRIFUGAL PUMP." 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. NOTE: THIS EVENT OCCURRED ON THE SAUDI ARABIA 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 701069076.
THE EVENT OCCURRED IN SAUDI ARABIA DURING TREATMENT. IT WAS REPORTED THAT A PATIENT WAS ON ECMO WITH ADDITIONALLY AN IMPELLA PUMP. ALL OF THE SUDDEN THE CARDIOHELP STARTED TO DISPLAY ¿PUMP DISPOSABLE ERROR STOP¿ AND THE FLOW CAME DOWN TO ZERO. THE CUSTOMER IMMEDIATELY CHECKED THE HLS SET, TUBINGS AND CANNULAS FOR ANY POSSIBLE KINK OR LEAK OR ANY VISIBLE DAMAGE. AFTER NO DAMAGE OR OBSTRUCTION WAS FOUND, THE PATIENT WAS HAND CRANKED WHEN THE HLS SET WAS REMOVED FROM THE CARDIOHELP DEVICE. THE ISSUE REMAINS, NO FLOW COULD BE ACHIEVED DURING HAND CRANKING ON THE HLS SET. THE CARDIOHELP AND HLS SET WERE REPLACED. NO HARM TO ANY PERSON HAS BEEN REPORTED. NEW INFORMATION RECEIVED ON 2025-02-19 THAT THE SEATING OF THE HLS SET WAS CHECKED AND IT WAS CORRECT. THE FAILURE OCCURRED ON DAY ONE OF TREATMENT. THERE WERE NO VISIBLE CLOTS IN THE SYSTEM. THE CUSTOMER CONFIRMED THAT THERE WAS NO FAULT WITH THE CARDIOHELP DEVICE. A GETINGE SERVICE TECHNICIAN INVESTIGATED THE CARDIOHELP DEVICE AND COULD NOT DUPLICATE ANY ERROR. THE DEVICE IS FUNCTIONING AS EXPECTED. COMPLAINT ID# 1231286
COMPLAINT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1038053 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | BE-HLS 5050 #SHLS SET ADVANCED 5.0 | 3000380949 | 04058863078298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |