CARDIOHELP
Report
- Report Number
- 8010762-2022-00517
- Event Type
- Malfunction
- Date Received
- December 23, 2022
- Date of Event
- December 6, 2022
- Report Date
- October 16, 2023
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- PMA / PMN Number
- K133598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS ONGOING. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2023-05-03. THE SENSOR PANEL WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2022-12-22 FOR THE PERIOD OF 2017-09-01 TO 2022-12-06. 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 2017-09-01. THE AFFECTED SENSOR PANEL IS BEING SHIPPED BACK FOR FURTHER INVESTIGATION BY THE GETINGE LIFE CYCLE ENGINEERING. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
THE INVESTIGATION IS ONGOING. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2022-12-06. THE SENSOR PANEL WAS DETERMINED TO BE DEFECT. THE REPAIR IS ONGOING. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2022-12-22 FOR THE PERIOD OF 2017-09-01 TO 2022-12-06. 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 2017-09-01. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
IT WAS REPORTED THAT THE CARDIOHELP FAILED THE INTERNAL PRESSURE TESTING. THE ARTERIAL PRESSURE READINGS WERE OUT OF SPECIFICATION. THE FAILURE OCCURRED DURING IN HOUSE REPAIR. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR. ALL THE READINGS EXCEPT FOR ZERO WERE OUT OF SPEC. THE FST TRIED A SECOND SENSOR TESTER WITH THE SAME RESULTS. THAT'S HOW IT WAS DETERMINED IT WAS A FAILURE OF THE SENSOR PANEL. THERE WERE NO VISUAL DEFECTS SEEN ON THE SENSOR PANEL. THE SENSOR PANEL WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE AFFECTED SENSOR PANEL WAS INVESTIGATED BY GETINGE LIFE-CYCLE-ENGINEERING (LCE) ON 2023-10-09 WITH THE FOLLOWING RESULT: THE MALFUNCTION COULD BE REPRODUCED IN THE LAB DURING AN INITIAL TEST, BUT COULD NOT BE REPRODUCED AFTER A FEW ATTEMPTS. THE MOST PROBABLE ROOT CAUSE OF THE OBSERVED AND REPORTED MALFUNCTION ARE DEPOSITS INSIDE THE CONNECTOR AT THE SENSOR PANEL. SINCE ONLY THE ARTERIAL PRESSURE WAS AFFECTED AND THE CALIBRATION VALUES COULD BE RETAINED, THE MOST PROBABLE CAUSE OF THE OBSERVED MALFUNCTION IS A FAILURE IN THE TRANSMISSION OF THE PRESSURE SIGNAL TO THE ELEMENTS PERFORMING THE SIGNAL PROCESSING. THE TRANSMISSION FAILURE IS PRESUMED TO BE CAUSED BY DEPOSITS INSIDE THE CONNECTOR AT THE SENSOR BRIDGE, PRESUMABLY CAUSED BY FLUID, THAT WERE REMOVED AFTER CONNECTING AND DISCONNECTING THE SENSOR TESTER SEVERAL TIMES. ACCORDING TO THE INSTRUCTION FOR USE OF THE INVOLVED DISPOSABLES (HLS SET ADVANCED 5.0 / 7.0, HIT SET ADVANCED 5.0 / 7.0, V2.3, CHAPTER 7.1 PREPARATION AND INSTALLATION AND QUADROX-IR SMALL ADULT / ADULT, CHAPTER 7.2 PRIMING THE SYSTEM) THE PRESSURE SENSORS HAVE TO BE CALIBRATED AND CHECKED BEFORE PRIMING. 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. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2022-12-22 FOR THE PERIOD OF 2017-09-01 TO 2022-12-06. 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 2017-09-01. BASED ON THE RESULTS THE REPORTED FAILURE "ARTERIAL PRESSURE READINGS OUT OF SPECIFICATION" COULD 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.
COMPLAINT ID: (B)(4).
IT WAS REPORTED THAT THE CARDIOHELP FAILED THE ARTERIAL PRESSURE TESTING. THE FAILURE OCCURRED DURING IN HOUSE REPAIR. COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2050911 | CARDIOHELP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | CARDIOHELP.I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |