CARDIOHELP
Report
- Report Number
- 8010762-2025-0000115
- Event Type
- Malfunction
- Date Received
- March 17, 2025
- Date of Event
- March 10, 2025
- Report Date
- May 28, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- UDI-DI
- 4037691658384
- PMA / PMN Number
- K133598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IT WAS REPORTED THAT THERE WAS A PRESSURE READING ISSUE DETECTED DURING TRANSPORT OF A PATIENT. THE PATIENT WAS UNDERGOING A REMOTE VENO-VENOUS (VV) CANNULATION IN A SEPARATE LOCATION. PRIOR TO PRIMING THE CARDIOHELP SYSTEM, THE INTERNAL PRESSURE (P-INT) HAD TO BE RE-ZEROED SEVERAL TIMES BEFORE THE CARDIOHELP DISPLAYED 0 MMHG. AFTER INITIATION OF VV ECMO, THE P-INT VALUE READINGS WERE UNEXPECTEDLY HIGH, ABOVE 500 MMHG, RESULTING IN THE DELTA PRESSURE (DELTA P) VALUE READING ABOVE 200 MMHG. THE CUSTOMER DETERMINED THAT THE HIGH P-INT AND DELTA P VALUES WERE INACCURATE AND CONTINUED THE PATIENT TRANSPORT TO THE HOSPITAL SITE WITH NO FURTHER INTERVENTIONS. UPON ARRIVAL IN THE HOSPITAL SITE, THE HLS CABLE WAS CHANGED. THE CUSTOMER MANUALLY TRANSDUCED PRESSURE FROM THE PIGTAILS USING AN EXTERNAL PRESSURE MONITOR. ACCORDING TO THE EXTERNAL PRESSURE MONITOR MEASUREMENTS, THE ARTERIAL PRESSURE AND POST OXYGENATOR PRESSURE WERE ACCURATE, AND THE VENOUS PRESSURE CORRESPONDED WITH THE EXPECTED PRESSURE VALUES FOR THE FLOWS SET BY THE CUSTOMER. THE EXTERNAL PRESSURE MONITOR MEASURED P-INT OF 260 MMHG AND DELTA P AROUND 30 MMHG. NO HARM TO ANY PERSON HAS BEEN REPORTED. ANY PRESSURE READING ISSUE OR PRESSURE ISSUE CAN LEAD TO A PUMP STOP IF THE INTERVENTIONS WERE SET BY THE USER. THEREFORE A REPORT IS REQUIRED. THE AFFECTED HLS SET WILL BE INVESTIGATED IN COMPLAINT# (B)(4) (MFG REPORT NUMBER 8010762-2025-0000120). A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION. NO PART WAS REPLACED. THE FAILURE COULD NOT BE REPLICATED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. ACCORDING TO THE RISK FILE OF THE CARDIOHELP DEVICE THE FOLLOWING ROOT CAUSES CAN LEAD TO THE REPORTED FAILURE:WRONG PRESSURE INFORMATION E.G.:- DISTURBED (EMI) PRESSURE SENSOR - RESPONSE TIME IS TOO LONG - TOO HIGH / LOW ATMOSPHERIC PRESSURE- DEFECTIVE DISPOSABLE PRESSURE SENSOR. ACCORDING TO THE INSTRUCTION FOR USE OF THE INVOLVED DISPOSABLES (HLS SET ADVANCED 5.0 / 7.0, HIT SET ADVANCED 5.0 / 7.0, V2.4, CHAPTER "PREPARATION AND INSTALLATION" AND QUADROX-IR SMALL ADULT / ADULT, CHAPTER "PRIMING THE SYSTEM") THE PRESSURE SENSORS HAVE TO BE CALIBRATED AND CHECKED BEFORE PRIMING. FURTHERMORE, 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. ADDITIONALLY, ACCORDING TO THE INSTRUCTION FOR USE (IFU) OF THE CARDIOHELP, CHAPTER "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. IN THE INSTRUCTIONS FOR USE (IFU) OF THE CARDIOHELP (CHAPTER "CLEANING AND DISINFECTION") THE CABLES AND THE WHOLE DEVICE SHOULD BE CLEANED AFTER EACH USE TO REMOVE SOILING OR RESIDUAL BLOOD. FURTHERMORE, IN THE IFU CHAPTER "CONNECTING THE SENSORS" IT IS STATED THAT THE SENSORS MUST BE KEPT CLEAN. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-03-12 FOR THE PERIOD OF 2017-08-16 TO 2025-03-11. 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 2017-08-16. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS. BASED ON THE RESULTS THE REPORTED FAILURE "PRESSURE READING FAULT" COULD NOT 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 SERVICE TECHNICIAN WILL INVESTIGATE THE AFFECTED CARDIOHELP. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
COMPLAINT ID# (B)(4).
IT WAS REPORTED THAT THERE WAS A PRESSURE READING ISSUE DURING TRANSPORTATION OF A PATIENT. THE PATIENT WAS UNDERGOING A REMOTE VENO-VENOUS (VV) CANNULATION IN A SEPARATE LOCATION. PRIOR TO PRIMING THE CARDIOHELP SYSTEM, THE INTERNAL PRESSURE (P-INT) HAD TO BE RE-ZEROED SEVERAL TIMES BEFORE THE CARDIOHELP DISPLAYED 0 MMHG. AFTER INITIATION OF VV ECMO, THE P-INT VALUE READINGS WERE UNEXPECTEDLY HIGH, ABOVE 500 MMHG, RESULTING IN THE DELTA PRESSURE (DELTA P) VALUE READING ABOVE 200 MMHG. THE CUSTOMER DETERMINED THAT THE HIGH P-INT AND DELTA P VALUES WERE INACCURATE AND CONTINUED THE PATIENT TRANSPORT TO THE HOSPITAL SITE WITH NO FURTHER INTERVENTIONS. UPON ARRIVAL IN THE HOSPITAL SITE, THE HLS CABLE WAS CHANGED. THE CUSTOMER MANUALLY TRANSDUCED PRESSURE FROM THE PIGTAILS USING AN EXTERNAL PRESSURE MONITOR. ACCORDING TO THE EXTERNAL PRESSURE MONITOR MEASUREMENTS, THE ARTERIAL PRESSURE AND POST OXYGENATOR PRESSURE WERE ACCURATE, AND THE VENOUS PRESSURE CORRESPONDED WITH THE EXPECTED PRESSURE VALUES FOR THE FLOWS SET BY THE CUSTOMER. THE EXTERNAL PRESSURE MONITOR MEASURED P-INT OF 260 MMHG AND DELTA P AROUND 30 MMHG. NO HARM TO ANY PERSON HAS BEEN REPORTED. ANY PRESSURE READING ISSUE OR PRESSURE ISSUE CAN LEAD TO A PUMP STOP IF THE INTERVENTIONS WERE SET BY THE USER. THEREFORE A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17325 | CARDIOHELP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | CARDIOHELP-I | 4037691658384 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Male |