D
Patient 1
DESCRIPTION FROM THE CUSTOMER REPORT: "PRIMING LEAKAGE FROM THE GAS EXHAUST OF THE OXYGENATOR." ADDITIONAL COMMENTS: "LEAKAGE DETECTED DURING DE-AIRING PROCEDURE WITH CONSEQUENT REPLACEMENT OF THE OXYGENATOR." (B)(4).
MAUDE MDR 4619440
- MDR report key
- 4619440
- Report number
- 8010762-2015-00227
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-02-19
- Date received
- 2015-03-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MICHAEL CAMPBELL
- Address
- KEHLER STRABE 31 RASTATT 76437 GM
- Phone
- 222-222-2229
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | QUADROX-ID 71000+VHK 71 | BO-VKMOD 71000 #QUADROX-ID 71000+VHK 71 | MAQUET CARDIOPULMONARY AG | DTN | BO-VKMOD 71000 | 70106.6952 | 92152854 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-03-18 | 0 | 1. O |
Event Narratives#
N
Patient 1
MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS, SHOWING A SIMILAR MALFUNCTION, HAVE BEEN TESTED AND UNDER OPTICAL MICROSCOPE DELAMINATION OF SOME GAS FIBERS WERE OBSERVED. HENCE, THE PRIMING SOLUTION OR BLOOD WAS ABLE TO FLOW INSIDE THE GAP BETWEEN THE GAS FIBERS AND POLYURETHANE AND THE GRAVITY GUIDED IT TO THE GAS EXITING PATH ALONG THE HOUSING. THE MANUFACTURER INITIATED A CUSTOMER NOTIFICATION CONCERNING THE PROBLEM, THE POTENTIAL RISK AND THE RECOMMENDED HANDLING IN THE EVENT THIS FAILURE OCCURS (B)(4). THE INVESTIGATION UNDER CAPA PROCESS (B)(4) HAS IDENTIFIED THAT THE ROOT CAUSE IS DUE TO THE MANUFACTURING PROCESS OF THE RAW MATERIAL FIBERS USED IN THE OXYGENATOR. IF, DURING THE SURFACE PRE-TREATMENT, A SYSTEM MALFUNCTION RESULTS IN A SYSTEM STOP, THE ENTIRE LENGTH OF THE FIBER IS NOT PROPERLY TREATED TO MODIFY THE SURFACE TENSION. IF THESE UNTREATED FIBERS ARE PRESENT IN THE EPOXY AREA OF THE OXYGENATOR, IT IS NOT PROPERLY FIXED IN THE EPOXY. WHEN THIS OCCURS, THE FIBERS ARE ABLE TO "SHRINK OUT" OF THE EPOXY AND RESULT IN THE REPORTED LEAKAGE. THE RAW MATERIAL MANUFACTURER HAS INITIATED STEPS TO REPEAT THE SURFACE PRE-TREATMENT TO ENSURE THAT THE PROPER SURFACE TENSION IS PRESENT ON THE ENTIRE LENGTH OF THE FIBERS.