TUBING SET
Report
- Report Number
- 8010762-2025-0000453
- Event Type
- Malfunction
- Date Received
- October 15, 2025
- Date of Event
- October 3, 2025
- Report Date
- December 2, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- PMA / PMN Number
- K112360
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- 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 THE USA DURING TREATMENT. IT WAS REPORTED THAT THERE WAS A PRESSURE READING ISSUE. THE INTERNAL PRESSURE PINT, DISPLAYED AS DASHES AND THE PRESSURE WAS FALSELY ELEVATED UP TO 400 MMHG. THE HLS SET AND THE CARDIOHELP DEVICE IN QUESTION WERE EXCHANGED. AFTERWARDS THE PRESSURE VALUES STABILIZED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS ANY PRESSURE ISSUE CAN LEAD TO A PUMP STOP DURING TREATMENT AND THE HLS SET WAS EXCHANGED, A REPORT IS REQUIRED. ON 2025-11-25, THE INFORMATION WAS RECEIVED THAT PRESSURE ISSUES OCCURRED PREVIOUSLY ON THE SAME CARDIOHELP (SERIAL#: (B)(6) DURING TREATMENT. THE FAILURE EVENT OCCURRED TWICE, ONCE ON 2025-09-30 AND 2025-10-03. THIS COMPLAINT INVESTIGATION IS FOR THE FAILURE EVENT THAT OCCURRED ON 2025-10-03. PRESSURE ISSUES WITH THIS FIRST PATIENT INVOLVED OCCURRED ON (B)(6) 2025. THIS PATIENT WAS TREATED WITH CARDIOHELP SERIAL#: (B)(6) AND HLS SET LOT#: 3000455960. FOR THIS EVENT CARDIOHELP COMPLAINT ID#: (B)(4), MFG REPORT NUMBER: 8010762-2025-0000519 WAS INITIATED. NO HLS COMPLAINT IS NEEDED, AS IT WAS CONFIRMED, THAT THE HLS SET DID NOT HAVE A MALFUNCTION, AND THE REPORTED PRESSURE ISSUES WERE RELATED TO THE CARDIOHELPS HLS CABLE. THE FAULT WAS NARROWED DOWN BY THE CUSTOMER TO THE HLS CABLES OF THE CARDIOHELP DEVICE. THE SECOND PATIENT WAS TREATED ON (B)(6) 2025. THE INTERNAL PRESSURE P-INT, DISPLAYED AS DASHES AND THE PRESSURE WAS FALSELY ELEVATED UP TO 400 MMHG. THIS PATIENT WAS TREATED WITH CH SERIAL#: (B)(6) AND HLS SET (LOT: UNKNOWN). FOR THIS EVENT THE CARDIOHELP DEVICE WILL BE INVESTIGATED UNDER COMPLAINT ID#: (B)(4), MFG REPORT NUMBER: 8010762-2025-0000452. THE HLS SET FOR THIS EVENT IS INVESTIGATED UNDER THIS COMPLAINT ID#: (B)(4). THE GETINGE SALES AND SERVICE UNIT CONFIRMED ON 2025-11-20 THAT REPORTED PRESSURE ISSUES WERE MOST PROBABLE CAUSED BY THE CARDIOHELPS HLS CABLE. IT WAS CONFIRMED THAT THERE WAS NO MALFUNCTION REGARDING THE INVOLVED HLS SET. IT WAS ADDITIONALLY CONFIRMED THAT THE HLS SET IS NOT AVAILABLE FOR RETURN AND INVESTIGATION. ACCORDING TO THE INSTRUCTION FOR USE (HLS SET, CHAPTER "PREPARATION AND INSTALLATION") THE PRESSURE SENSORS HAVE TO BE CHECKED BEFORE PRIMING. IN GENERAL, IT SHOULD BE NOTED THAT PRE-PRIMING CAN HAVE A NEGATIVE IMPACT ON THE SENSOR FUNCTION AND THE ASSOCIATED PRESSURE VALUES AND CAN LEAD TO THE OUTPUT OF UNEXPECTED / IMPLAUSIBLE PRESSURE VALUES SHORTLY BEFORE USE, AS INDICATED IN CHAPTER "PRIMING THE SYSTEM", WHERE IT SAYS "ONLY FILL THE SYSTEM SHORTLY BEFORE USE AND IN ACCORDANCE WITH THE PRIMING INSTRUCTIONS. CALIBRATION VALUES ARE LOST WHEN THE DRIVE UNIT IS SWITCHED OFF". 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. NO DEVICE HISTORY REVIEW COULD BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. 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. BASED ON THE RESULTS THE REPORTED PRESSURE ISSUES COULD BE CONFIRMED, BUT WERE NOT RELATED TO THE INVOLVED HLS SET. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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: 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 USA. IT WAS REPORTED THAT THERE WAS A PRESSURE READING ISSUE. THE INTERNAL PRESSURE P-INT, DISPLAYED AS DASHES AND THE PRESSURE WAS FALSELY ELEVATED UP TO 400 MMHG. THE HLS SET WAS EXCHANGED. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE AFFECTED CARDIOHELP DEVICE WILL BE INVESTIGATED IN COMPLAINT #(B)(4) (REPORTED UNDER MFG REPORT NUMBER 8010762-2025-0000452). AS ANY PRESSURE ISSUE CAN LEAD TO A PUMP STOP DURING TREATMENT AND THE HLS SET WAS EXCHANGED, A REPORT IS REQUIRED. COMPLAINT ID (B)(4).
COMPLAINT ID#: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 277835 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female |