MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2014-11-26 for VENOUS BUBBLE TRAP WITH & W/O BIOLINE COATING BO-HQV1519 70104.9692 manufactured by Maquet Cardiopulmoary Ag.
[21326946]
On (b)(6) 2012, (b)(6), reported that the venous bubble trap (vbt) in the bo-hqv1519 mecc set (article number: 70104. 9692, serial number: unknown) "always breaks the upper connection". (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21737451]
(b)(4). Previous investigations have determined that the cause is too little glue applied during the manufacturing process. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2014-00420 |
| MDR Report Key | 4278463 |
| Report Source | 00,01,05,06 |
| Date Received | 2014-11-26 |
| Date of Report | 2012-03-20 |
| Date of Event | 2012-03-20 |
| Date Facility Aware | 2012-03-20 |
| Report Date | 2012-03-20 |
| Date Reported to Mfgr | 2012-03-20 |
| Date Mfgr Received | 2012-03-20 |
| Date Added to Maude | 2014-11-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | TINA EVANCHO |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097265 |
| Manufacturer G1 | MAQUET CARDIOPULMOARY AG |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT, 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENOUS BUBBLE TRAP WITH & W/O BIOLINE COATING |
| Generic Name | DEFOAMER, CARDIOPULMONARY BYPASS |
| Product Code | DTP |
| Date Received | 2014-11-26 |
| Model Number | BO-HQV1519 |
| Catalog Number | 70104.9692 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMOARY AG |
| Manufacturer Address | KEHLER STRASSE 31 RASTATT, 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-26 |