CARDIOHELP
Report
- Report Number
- 8010762-2023-00188
- Event Type
- Malfunction
- Date Received
- April 24, 2023
- Date of Event
- April 12, 2023
- Report Date
- June 28, 2023
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- PMA / PMN Number
- K133598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IT WAS REPORTED THAT THE VENOUS PRESSURE WAS DISPLAYED ABNORMAL ON THE CARDIOHELP. INFORMATION RECEIVED THAT THE USER MANAGED TO DISPLAY THE VENOUS PRESSURE BY MOVING THE PRESSURE CABLE. THE FAILURE OCCURRED DURING TREATMENT. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2023-04-11. THE CONNECTION CABLE FOR INTERNAL SENSORS WILL BE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE LOG FILES OF THE REPORTED CARDIOHELP WERE REVIEWED AND THE ERROR MESSAGE "PVEN SENSOR DISCONNECTED" WAS LOGGED MULTIPLE TIMES ON THE DATE OF EVENT. IT WAS CONFIRMED BY THE FST, THAT NO TRACE OR IMPACT WERE DETECTED OUTSIDE OF THE CABLE. A SIMILAR FAILURE WAS INVESTIGATED BY GETINGE LIFE CYCLE ENGINEERING (LCE) ON 2022-11-02 . THE NATURE OF THE ERROR COULD BE TRACED BACK TO A MISSING ELECTRICAL CONNECTION WITHIN THE CABLE. THE ROOT CAUSE FOR THE MISSING CONNECTION IS A BROKEN WIRE WITHIN THE CABLE, WHICH IS ORIGINATED FROM EXTERNAL FORCE. FURTHERMORE, ACCORDING TO THE RISK ANALYSIS V24 FOLLOWING ROOT CAUSES CAN ALSO LINKED TO THE REPORTED FAILURE: - A MECHANICAL DAMAGE E.G. DUE TO TOO HIGH FORCES DURING CONNECTION/ DISCONNECTION OF THE CABLE - BROKEN FIBER INSIDE THE CABLE 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. MOREOVER, ACCORDING TO THE INSTRUCTION FOR USE (CARDIOHELP, CHAPTER 5.3 "CONNECTION THE SENSORS") IT IS STATED TO ENSURE THAT THE CONNECTED SENSORS ARE NOT DEFECTIVE AND TO NOT USE, IF THERE IS A VISIBLE DAMAGE. FURTHERMORE, ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) OF THE CARIDOHELP (CHAPTER 10 CLEANING AND DISINFECTION) THE CABLES AND THE WHOLE DEVICE SHOULD BE CLEANED AFTER EACH USE TO REMOVE SOILING OR RESIDUAL BLOOD. FURHTERMORE IN CHAPTER 5.3 CONNECTING THE SENSORS IT IS STATED THAT THE SENSORS MUST BE KEPT CLEAN. THE DEVICE WAS MANUFACTURED ON 2014-04-16. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2023-04-26 FOR THE PERIOD OF 2014-04-16 TO 2023-04-12. 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. BASED ON THE RESULTS THE REPORTED FAILURE "VENOUS PRESSURE WAS DISPLAYED ABNORMAL ON THE CARDIOHELP" 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 GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2023-04-11. THE CONNECTION CABLE FOR INTERNAL SENSORS WILL REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. A FOLLOW UP WILL SUBMITTED WHEN ADDITIONAL INFORMATION BECOME AVAILABLE.
A FOLLOW UP WILL SUBMITTED WHEN ADDITIONAL INFORMATION BECOME AVAILABLE.
COMPLAINT ID: (B)(4).
COMPLAINT ID: (B)(4).
IT WAS REPORTED THAT THE VENOUS PRESSURE WAS DISPLAYED ABNORMAL ON THE CARDIOHELP DURING TREATMENT. INFORMATION RECEIVED THAT THE USER MANAGED TO DISPLAY THE VENOUS PRESSURE BY MOVING THE PRESSURE CABLE. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1275128 | CARDIOHELP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | CARDIOHELP-I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |