MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-03-18 for QUADROX-ID 71000+VHK 71 BO-VKMOD 71000 70106.6952 manufactured by Maquet Cardiopulmonary Ag.
[5654393]
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).
Patient Sequence No: 1, Text Type: D, B5
[13105390]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00227 |
| MDR Report Key | 4619440 |
| Report Source | 01,05,06 |
| Date Received | 2015-03-18 |
| Date of Report | 2015-02-19 |
| Date of Event | 2015-02-19 |
| Date Mfgr Received | 2015-02-19 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2015-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRABE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 2229321132 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUADROX-ID 71000+VHK 71 |
| Generic Name | BO-VKMOD 71000 #QUADROX-ID 71000+VHK 71 |
| Product Code | DTN |
| Date Received | 2015-03-18 |
| Model Number | BO-VKMOD 71000 |
| Catalog Number | 70106.6952 |
| Lot Number | 92152854 |
| Device Expiration Date | 2016-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-18 |