CARDIOHELP
Report
- Report Number
- 8010762-2023-00046
- Event Type
- Malfunction
- Date Received
- January 26, 2023
- Date of Event
- January 16, 2023
- Report Date
- May 26, 2023
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- PMA / PMN Number
- K133598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS ONGOING. AS CONFIRMED BY THE GETINGE FIELD SERVICE TECHNICIAN ON 2023-01-30 THE AFFECTED FLOW/BUBBLE SENSOR WAS REPLACED, WHICH SOLVED THE REPORTED FAILURE. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2023-02-28 FOR THE PERIOD OF 2019-06-01 TO 2023-01-16. 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 2019-06-01. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
IT WAS REPORTED THAT THERE WAS A LOOSE CONTACT AT THE FLOW BUBBLE SENSOR. THE FAILURE OCCURRED DURING TREATMENT. THERE WAS NO PUMP STOP REPORTED. THE GETINGE FIELD SERVICE TECHNICIAN REPLACED THE AFFECTED FLOW/BUBBLE SENSOR ON 2023-01-30, WHICH SOLVED THE REPORTED FAILURE. ANY MANIPULATION OF THE CABLE RESULTED IN FALSE READINGS BUT NO VISUAL DAMAGE WAS IDENTIFIED ON THE CABLE. THE BUBBLE SENSOR WAS NOT PROVIDED BY THE CUSTOMER, THEREFORE THE EXACT ROOT CAUSE REMAINS UNKNOWN. HOWEVER THE MOST PROBABLE ROOT CAUSE WAS DETERMINED AS A LOOSE CONNECTION INSIDE THE CABLE OR THE FLOW BUBBLE SENSOR. ON 2023-02-13 THE GETINGE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE CARDIOHELP INSTRUCTION FOR USE IN CHAPTER 5.3 "CONNECTION THE SENSORS" EXPLAINED HOW TO ENSURE THAT THE CONNECTED SENSORS ARE NOT DEFECTIVE AND SHOULD NOT BE USE, IF THERE IS A VISIBLE DAMAGE. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2023-02-28 FOR THE PERIOD OF 2019-06-01 TO 2023-01-16. 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 2019-06-01. BASED ON THE RESULTS THE REPORTED FAILURE "LOOSE CONTACT AT THE FLOW BUBBLE" 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.
A FOLLOW UP WILL SUBMITTED WHEN ADDITIONAL INFORMATION BECOME AVAILABLE.
COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
A LOOSE CONTACT AT THE FLOW BUBBLE SENSOR WAS REPORTED DURING TREATMENT. ANY MANIPULATION OF THE CABLE CAUSED INCORRECT INFORMATION. THERE WAS NO PUMP STOP OR CARDIOHELP EXCHANGE DUE TO THIS EVENT. FURTHER THERE WAS NO VISIBLE DAMAGE ON THE CABLE. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1176678 | CARDIOHELP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | CARDIOHELP-I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |