TUBING SETS
Report
- Report Number
- 8010762-2024-00395
- Event Type
- Malfunction
- Date Received
- August 8, 2024
- Date of Event
- August 2, 2024
- Report Date
- February 14, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DWE
- PMA / PMN Number
- K080592
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE SAMPLE WAS INVESTIGATED AT MAQUET CARDIOPULMONARY GMBH LABORATORY ON 2024-10-02. A VISUAL INSPECTION WAS PERFORMED AND FOUND THAT THE CLAIMED QUADROX.I ADULT SHOWED NO DAMAGES LIKE CRACKS, SCRATCHES, DEFORMATIONS, IMPACT POINTS OR BREAKS. BY PERFORMING THE LEAK TEST ON THE BLOOD SIDE, A LEAK IMMEDIATELY OCCURRED AT THE LUER OF THE BLOOD OUTLET CONNECTOR. THE CAUSE OF THE LEAKAGE IS A CRACK ON THE LUER OF THE DEAIRING. THE COMPLAINT COULD THEREFORE BE CONFIRMED. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.
IT WAS REPORTED THAT BLOOD LEAKAGE WAS DETECTED IN THE ARTERIAL LINE OF OXYGENATOR. THE FAILURE DETECTED DURING TREATMENT. IT WAS REPORTED THIS FAILURE REPEATEDLY OCCURS ON LUER LOCK CONNECTION OF FLOOD BLOOD OUTLET. CUSTOMER CONCERNS ABOUT THE DESIGN DIFFERENCE OF LUER LOCK CONNECTORS BETWEEN BLOOD INLET AND OUTLET. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE SAMPLE WAS INVESTIGATED AT MAQUET CARDIOPULMONARY GMBH LABORATORY ON 2024-10-02. A VISUAL INSPECTION WAS PERFORMED AND FOUND THAT THE CLAIMED QUADROX.I ADULT SHOWED NO DAMAGES LIKE CRACKS, SCRATCHES, DEFORMATIONS, IMPACT POINTS OR BREAKS. BY PERFORMING THE LEAK TEST ON THE BLOOD SIDE, A LEAK IMMEDIATELY OCCURRED AT THE LUER OF THE BLOOD OUTLET CONNECTOR. THE CAUSE OF THE LEAKAGE IS A CRACK ON THE LUER OF THE DEAIRING. THE COMPLAINT COULD THEREFORE BE CONFIRMED, BUT NOT RELATED WITH THE BLOOD OUTLET CONNECTOR ITSELF, THE FAILURE WAS RELATED TO LLM CONNECTOR (700000331). BASED ON THE INVESTIGATION RESULTS, THERE WAS NOT ANY NON-CONFORMITIES DETECTED FOR THE BLOOD OUTLET CONNECTOR¿S ITSELF. HOWEVER, THE FAILURE WAS FOUND AS RELATED WITH LUER CONNECTOR AND THEREFORE THIS COMPLAINT COULD BE CONFIRMED. THE PROBABLE CAUSE OF THE FAILURE WAS FOUND AS RELATED WITH MATERIAL. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED QUADROX-I SMALL ADULT WITH LOT # 3000336654 WAS REVIEWED ON 2024-08-19. ACCORDING TO THE DHR RESULTS, THE PRODUCT QUADROX-I SMALL ADULT PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED BE-HQV 19312 WITH LOT# 3000358313 WAS REVIEWED ON 2024-09-20. ACCORDING TO THE DHR RESULT, THE PRODUCT BE-HQV 19312 PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. A NON-CONFORMITY RECORD HAS BEEN INITIATED FOR THE RELATED FAILURE CRACK & SCRATCH ON 700000330 ¿ 700000331 CONNECTORS. THIS NON-CONFORMITY RECORD WAS INITIATED DUE TO A NOTIFICATION WAS PERFORMED BY MCP AND CAUSED BY ANOTHER PRODUCT GROUP COMPLAINT INVESTIGATION'S RESULTS. AS THE FAILURE WAS FOUND AS SAME WITH THE NON-CONFORMITY RECORD, FURTHER INVESTIGATION OF THE CAUSE AND ACTIONS WILL BE DETERMINED & PERFORMED WITHIN THIS NON-CONFORMITY. 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.
COMPLAINT # (B)(4).
IT WAS REPORTED THAT LEAKAGE WAS DETECTED IN THE ARTERIAL LINE OF OXYGENATOR AND THE LEAKAGE OF BLOOD IS DRIP BY DROP. THE FAILURE DETECTED DURING TREATMENT. NO HARM OR DEATH TO ANY PERSON WAS REPORTED. COMPLAINT # (B)(4).
COMPLAINT # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2402964 | TUBING SETS | TUBING, PUMP, CARDIOPULMONARY BYPASS | DWE | MAQUET CARDIOPULMONARY GMBH | BE-HQV 19312 | 3000358313 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |