HEART LUNG MACHINE
Report
- Report Number
- 8010762-2025-0000494
- Event Type
- Malfunction
- Date Received
- November 11, 2025
- Date of Event
- October 31, 2025
- Report Date
- November 20, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- UDI-DI
- 04037691773032
- PMA / PMN Number
- K943803
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT ONSITE FOR INVESTIGATION OF THE DEVICE. THE INVESTIGATION IS ONGOING. AS SOON AS NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. NOTE: THIS EVENT OCCURRED ON THE INDIAN MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT HL 20¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K943803. 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 HL 20 WITH CATALOG NUMBER 701043262.
IT WAS STATED THAT THE HL20 RPM DISPLAYED THE ERROR MESSAGE RUNAWAY. THE ISSUE WAS OBSERVED DURING ROUTINE CHECKUP. NO HARM TO ANY PERSON HAS BEEN REPORTED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR RUNAWAY INDICATES THAT THE PUMP HEAD SPEED IS EXCEEDING THE AMOUNT SET AT THE PUMP ROTARY KNOB BY MORE THAN 10 PERCENT. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR. THE REPORTED FAILURE WAS NOT REPRODUCIBLE. THE BELT TENSION WAS ADJUSTED AS PREVENTIVE MEASURE. NO PART WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE MOST PROBABLE ROOT CAUSE CAN BE LINKED TO HL20 RISK ASSESSMENT: WRONG PUMP SPEED BECAUSE OF: - COMMUNICATION ERROR (E.G. WRONG RATIO BETWEEN MASTER-SLAVE PUMPS DUE TO COMMUNICATION ERROR), - PUMP RUNAWAY. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON (B)(6) 2025 FOR THE PERIOD OF (B)(6) 2019 TO (B)(6) 2025. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE DEVICE WAS MANUFACTURED ON (B)(6) 2019. 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. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE ERROR MESSAGE: RUNAWAY COULD NOT BE CONFIRMED. 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.
THE EVENT OCCURRED IN INDIA. IT WAS STATED THAT THE HL20 RPM DISPLAYED THE ERROR MESSAGE RUNAWAY. THE ISSUE WAS OBSERVED DURING ROUTINE CHECKUP. NO HARM TO ANY PERSON HAS BEEN REPORTED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR RUNAWAY INDICATES THAT THE PUMP HEAD SPEED IS EXCEEDING THE AMOUNT SET AT THE PUMP ROTARY KNOB BY MORE THAN 10 PERCENT. THE REPORTED BEHAVIOR CAN CAUSE AN UNINTENTIONAL PUMP STOP. THEREFORE, A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1926994 | HEART LUNG MACHINE | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | HL 20 | 04037691773032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |