CARDIOHELP
Report
- Report Number
- 8010762-2023-00563
- Event Type
- Malfunction
- Date Received
- November 13, 2023
- Date of Event
- October 25, 2023
- Report Date
- August 21, 2024
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- PMA / PMN Number
- K133598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IT WAS REPORTED THAT THE PATIENT LEAKAGE TEST FAILED. ACCORDING TO THE TECHNICIAN THE LEAKAGE CURRENT WAS HIGHER THAN THE SPECIFICATION. THE FAILURE OCCURRED DURING MAINTENANCE. THE DEVICE CAUSED THE COMPLAINT AND WAS NOT ABLE TO WORK AS PER FACTORY¿S SPECIFICATIONS. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS PERFORMING MAINTENANCE ON 2023-11-10. THE SENSOR PANEL WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. A SIMILAR FAILURE OF THE PATIENT LEAKAGE TEST WAS INVESTIGATED BY GETINGE LIFE-CYCLE-ENGINEERING (LCE) ON 2023-08-11. THE EXCEEDING OF THE VALUE LIMIT AFFECTS ONLY THE SENSOR PANEL DA0, IN WHICH A HIGHER CAPACITOR VALUE WAS INSTALLED. AS AN ACTION THE SENSOR PANEL WAS REVISED UNDER A CAPA. REFERRING TO THE INSTRUCTION FOR USE OF THE CARDIOHELP DEVICE (CHAPTER 4.5 "CONNECTING EXTERNAL DEVICES (OPTIONAL)") IT IS STATED TO CHECK THE TOTAL LEAKAGE CURRENTS IF THE CARDIOHELP DEVICE WILL BE USED TOGETHER WITH OTHER MEDICAL DEVICES. ADDITIONALLY, AS STATED IN THE SERVICE MANUAL (CARDIOHELP SYSTEM, SERVICE REQUIREMENTS) ONLY AUTHORIZED SERVICE TECHNICIANS ARE ALLOWED TO CARRY OUT SERVICE-RELATED WORK. THUS THE ISSUE CAN ONLY OCCUR DURING SERVICE OF AN AUTHORIZED SERVICE TECHNICIAN. THE PRODUCT IN QUESTION WAS PRODUCED ON 2010-12-01. THE REVIEW OF THE NON-CONFORMITIES (NC) HAS BEEN PERFORMED ON 2023-08-11. AN NC REGARDING THE REPORTED FAILURE WAS FOUND. IN ORDER TO ADDRESS THIS FAILURE A CAPA WAS INITIATED ON 2022-08-03 (ONGOING). THE FOLLOWING CORRECTIVE ACTION IS IMPLEMENTED IN THE FSCA#881841 FOR THE FAILURE CONCERNING THE PATIENT LEAKAGE CURRENT TEST: CONTACT THE CUSTOMER TO ARRANGE THE PERFORMANCE OF THE PATIENT LEAKAGE CURRENT TEST ACCORDING TO IEC 62353 AND SUBSEQUENT REPAIR, IF NECESSARY OR THE RETURN OF THE CARDIOHELP TO A GETINGE REPRESENTATIVE BASED ON THE RESULTS THE REPORTED FAILURE " PATIENT LEAKAGE TEST FAILED " COULD BE CONFIRMED. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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.
UDI RELATED DATA QUALITY UPDATES ONLY. THIS FOLLOW-UP EMDR IS SUBMITTED TO PROVIDE A STATEMENT REGARDING THE LACK OF UDI NUMBER FOR THE DEVICE RELATED TO THIS EVENT. NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THIS MACHINE (CARDIOHELP) HAS BEEN MANUFACTURED ON 2010. ALL MAQUET CARDIOPULMONARY CLASS II PRODUCTS MANUFACTURED UNTIL 2015 DO NOT HAVE UDI ENTRIES. THEREFORE, NO UDI NUMBER IS AVAILABLE. THE INVESTIGATION RESULTS HAVE NOT BEEN CHANGED SINCE THE LAST EMDR (MFG REPORT NUMBER).
A GETINGE SERVICE TECHNICIAN WILL INVESTIGATE THE AFFECTED CARDIOHELP. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
COMPLAINT ID # (B)(4).
COMPLAINT ID # (B)(4).
IT WAS REPORTED THAT THE PATIENT LEAKAGE TEST FAILED. THE FAILURE OCCURRED DURING MAINTENANCE. COMPLAINT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236672 | CARDIOHELP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | CARDIOHELP-I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |