TUBING SETS
Report
- Report Number
- 8010762-2025-0000198
- Event Type
- Malfunction
- Date Received
- May 2, 2025
- Date of Event
- April 18, 2025
- Report Date
- July 2, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DWE
- PMA / PMN Number
- K053025
- 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 PEDIATRIC OXYGENATOR WAS FOUND NON-FUNCTIONAL AT THE START OF CPB. THE OXYGENATOR WAS REPLACED INTRAOPERATIVELY WITH ANOTHER UNIT FROM THE SAME BATCH WITHOUT ANY CLINICAL CONSEQUENCE. NO HARM OR DEATH TO ANY PERSON WAS REPORTED. FURTHER INFORMATION WAS RECEIVED ON 2025-06-23, THAT STATES THERE COULD NOT BE FOUND ANY FAILURE WITH THE OXYGEN SUPPLY AS THE FAILURE WAS RESOLVED WITH THE CHANGE OF OXYGENATOR. THE ONLY AVAILABLE INFORMATION IS A DROP ON PAO2. THE PRODUCT WAS INVESTIGATED AT MAQUET CARDIOPULMONARY GMBH LABORATORY ON (B)(6) 2025. TIGHTNESS TEST WAS PERFORMED AND PASSED FOR THE BLOOD SIDE, WATER SIDE, AND GAS SIDE. ADDITIONALLY, THE FLOW TEST WAS PASSED. FURTHER, A VISUAL INSPECTION WAS PERFORMED AND NO DEFORMATION WAS OBSERVED HOWEVER IT SHOWS BLOOD CLOTS INSIDE OXYGENATOR. BASED ON THE LABORATORY INVESTIGATION RESULTS, OXYGENATOR WAS FOUND AS FUNCTIONAL. THEREFORE, COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION RESULTS, THERE COULD NOT BE FOUND ANY FAILURE WITH THE RECEIVED OXYGENATOR. IT IS IMPOSSIBLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED FAILURE HOWEVER POSSIBLE CAUSES ARE: PROBLEM WITH OXYGEN SUPPLY SYSTEM, USER ERROR, CLOT FORMATION THESE CAUSES COULD NOT BE CONFIRMED. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED QUADROX-I NEO WITH LOT # 3000409093 WAS REVIEWED ON 2025-05-16. ACCORDING TO THE DHR RESULTS, THE PRODUCT QUADROX-I NEO PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION ON MANUFACTURING ISSUES. THUS, PRODUCTION RELATED INFLUENCES ARE UNLIKELY. FURTHER, THE LOT NUMBER OF THE AFFECTED CUSTOM TUBING SET 'HQV 140701#PACK STANDARD VKMO 11000' WAS NOT PROVIDED BY CUSTOMER. HOWEVER, THE FOLLOWING BATCH NUMBERS WERE FOUND VIA SAP THAT ARE SOLD TO CHU BORDEAUX - HOPITAL PELLEGRIN WITH THE CONSUMED BATCH OF OXYGENATOR: #3000443403, #3000422280 AND #3000414709. THE PRODUCTION HISTORY RECORDS (DHR) OF THE AFFECTED HQV 140701#PACK STANDARD VKMO 11000 WITH LOTS #3000443403, #3000422280 AND #3000414709 WERE REVIEWED ON 2025-07-05. ACCORDING TO THE DHR RESULT, THE PRODUCT HQV 140701#PACK STANDARD VKMO 11000 PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION ON MANUFACTURING ISSUES. THUS, PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND PRODUCT 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.
THE SAMPLE WAS INVESTIGATED AT MAQUET CARDIOPULMONARY GMBH LABORATORY ON (B)(6) 2025. TIGHTNESS TEST WAS PERFORMED AND PASSED FOR THE BLOOD SIDE, WATER SIDE, AND GAS SIDE. ADDITIONALLY, THE FLOW TEST WAS PASSED. FURTHER, A VISUAL INSPECTION WAS PERFORMED AND NO DEFORMATION WAS OBSERVED HOWEVER IT SHOWS BLOOD CLOTS INSIDE OXYGENATOR. BASED ON THE LABORATORY INVESTIGATION RESULTS, OXYGENATOR WAS FOUND AS FUNCTIONAL. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.
COMPLAINT # (B)(4).
(B)(4).
IT WAS REPORTED THAT THE PEDIATRIC OXYGENATOR WAS FOUND NON-FUNCTIONAL AT THE START OF CPB. THE OXYGENATOR WAS REPLACED INTRAOPERATIVELY WITH ANOTHER UNIT FROM THE SAME BATCH WITHOUT ANY CLINICAL CONSEQUENCE. NO HARM OR DEATH TO ANY PERSON WAS REPORTED. SINCE THE FAILURE OCCURRED DURING PATIENT USE, THE COMPLAINT IS REPORTABLE. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192483 | TUBING SETS | TUBING, PUMP, CARDIOPULMONARY BYPASS | DWE | MAQUET CARDIOPULMONARY GMBH | HQV 140701 | N/I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 MO | Unknown | Other |