CARDIOHELP
Report
- Report Number
- 8010762-2023-00139
- Event Type
- Malfunction
- Date Received
- March 16, 2023
- Date of Event
- January 1, 2023
- Report Date
- April 21, 2023
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- PMA / PMN Number
- K133598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IT WAS REPORTED THAT THE HLS DISPOSABLE CABLE IS FAULTY. IT WAS LATER ADDITIONALLY REPORTED THAT THE DEVICE SHOWED ABNORMAL BEHAVIOR ON START-UP, SHOWING HIGH PVEN (VENOUS PRESSURE) VALUES COMBINED WITH AN ALARM. THE FAILURE OCCURRED DURING CHECKOUT AND BEFORE PATIENT USE. THE CUSTOMER SWAPPED IT WITH A SPARE CABLE. THE CUSTOMER REPLACED THE HLS CABLE WITH A SPARE PART AND GOT SENT A NEW HLS CABLE FROM THE GETINGE FIELD SERVICE TECHNICIAN (FST) TO REPLACE THE DEFECTIVE ONE. SINCE NO REPAIR AND INVESTIGATION HAS BEEN PERFORMED BY A FST AND NO DETAILED INFORMATION WERE PROVIDED, NO EXACT ROOT CAUSE COULD BE DETERMINED. ACCORDING TO THE RISK ANALYSIS OF THE CARDIOHELP DEVICE FOLLOWING ROOT CAUSES CAN ALSO LEAD 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. HOWEVER, SIMILAR FAILURES HAVE BEEN INVESTIGATED BY GETINGE LIFE CYCLE ENGINEERING (LCE) IN THE PAST, WHERE A BROAD SPECTRUM OF POSSIBLE ROOT CAUSES COULD BE IDENTIFIED: DEPOSIT WAS DETECTED ON THE CABLE SOCKET DURING VISUAL INSPECTION. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED AS WETTING OF THE SOCKET PLANE OF THE PLUG WITH SALT-CONTAINING LIQUIDS (PRIMING). INSTEAD OF THE EXPECTED 1 M THICK GOLD COATING ON THE PIN SURFACE OF THE CONNECTOR THERE IS A SOFT SURFACE OF UNKNOWN ORIGIN AND COMPOSITION. THIS COATING CREATES A HIGH CONTACT RESISTANCE. THE FAILURE COULD BE TRACED BACK TO A BROKEN ELECTRICAL CONNECTION WITHIN THE CABLE. 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. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2023-03-07 FOR THE PERIOD OF 2018-03-05 TO 2023-01-01. 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 2018-03-05. BASED ON THE RESULTS THE REPORTED FAILURE "HLS CABLE IS FAULTY - SHOWING HIGH PVEN VALUES ON START-UP" 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. H3 OTHER TEXT : ON-SITE VISIT WAS NOT REQUESTED BY THE CUSTOMER.
THE CUSTOMER REPLACED THE HLS CABLE WITH A SPARE PART AND GOT SENT A NEW HLS CABLE FROM THE GETINGE FIELD SERVICE TECHNICIAN (FST) TO REPLACE THE DEFECTIVE ONE. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
COMPLAINT ID: (B)(4).
IT WAS REPORTED THAT THE DEVICE HAD A HIGH VALUE ON PVEN (VENOUS PRESSURE) AND GAVE OUT AN ALARM. AFTER THE CONNECTION CABLE FOR DISPOSABLES WAS SWAPPED BY THE CUSTOMER, THE UNIT WAS WORKING FINE. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID:(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 903845 | CARDIOHELP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | CARDIOHELP-I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |