MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-08-07 for BO-VBT 160-J#BO-VENOUS BUBBLE TRAP- STERILE 70104.8887 manufactured by Maquet Cardiopulmonary Ag.
[4999770]
It was reported that during use on a pt. Accumulation of air was observed on the lower side of the de-airing cock. Air accumulation was observed soon after manipulating the de-airing cock. The customer suspects the failure is due to the back-flow valve and/ or the product housing. Device use was continued with no reported pt effect. Blood flow rate: 3. 6l/min. Aspiration pressure: -56mmhg". (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12484483]
(b)(4). A health hazard eval was initiated and the hazard has been defined. Based on new info available (b)(4) 2014, a re-assessment of the reporting obligation was performed and this event was determined to be reportable. Maquet cardiopulmonary is aware of similar complaints and an internal process (b)(4) was initiated to determine the root- cause and implement the appropriate corrective action. A supplemental medwatch will be submitted when add'l info becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2014-00295 |
| MDR Report Key | 4219065 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-08-07 |
| Date of Report | 2014-08-01 |
| Date of Event | 2001-07-15 |
| Date Facility Aware | 2014-08-06 |
| Report Date | 2014-08-07 |
| Date Mfgr Received | 2014-08-01 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-11-06 |
| 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 | JANICE PEVIDE |
| Manufacturer Street | 45 BARBOUR POND DR |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097753 |
| Manufacturer G1 | MAQUET CARDIOPULMONARY 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 | BO-VBT 160-J#BO-VENOUS BUBBLE TRAP- STERILE |
| Generic Name | VBT (VENOUS BUBBLE TRAP) |
| Product Code | DTP |
| Date Received | 2014-08-07 |
| Returned To Mfg | 2014-07-28 |
| Catalog Number | 70104.8887 |
| Lot Number | 92125382 |
| Device Expiration Date | 2015-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-07 |