MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2015-07-28 for VENOUS HARDSHELL CARDIOTOMY RESERVOIR VHK 71000 70106.2838 manufactured by Maquet Cardiopulmonary Ag.
[6634331]
On (b)(6) 2014 at the (b)(6) in the (b)(6) it was reported that after bypass surgery was started there was a large volume coming to the reservoir vhk 71000 from lot number 70098489 from the three suckers. There was a lot of frothing visible. Acts were maintained at a normal bypass level throughout the case. This patient was cooled and rewarmed. Oxygenator was performing throughout. Bypass ended after 239 minutes. As a precaution the reservoir was changed out in case there is a need for further bypass. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[14305222]
Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). The returned sample was visually inspected in the laboratory and there were no defects found and the cause of formation of foam in the reservoir could not be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00493 |
| MDR Report Key | 4944968 |
| Report Source | 01,06 |
| Date Received | 2015-07-28 |
| Date of Report | 2014-09-30 |
| Date of Event | 2014-09-30 |
| Date Facility Aware | 2014-09-30 |
| Report Date | 2014-09-30 |
| Date Reported to Mfgr | 2014-09-30 |
| Date Mfgr Received | 2014-09-30 |
| Date Added to Maude | 2015-07-28 |
| 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 |
| Health Professional | 0 |
| 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 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 | VENOUS HARDSHELL CARDIOTOMY RESERVOIR |
| Generic Name | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
| Product Code | DTN |
| Date Received | 2015-07-28 |
| Returned To Mfg | 2014-10-10 |
| Model Number | VHK 71000 |
| Catalog Number | 70106.2838 |
| Lot Number | 70098489 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | KEHLER STRASSE 31 RASTATT, 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-28 |