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 2015-07-28 for VENOUS HARDSHELL CARDIOTOMY RESERVOIR VHK 71000 70106.3805 manufactured by Maquet Cardiopulmonary Ag.
[20035613]
On (b)(6) 2014 at the (b)(6) it was reported that there were large quantities of air being sucked into the venous line and the bo-02971 vhk 71000 venous reservoir from lot number 92119954 during pulsatile priming. The air was observed to be coming from the venous temperature probe on top of the venous inlet. The user tried to correct the problem by tightening the luer lock of the temperature probe but this did not resolve the issue. Eventually they removed the temperature venous probe and replaced it with a plug. Problem was solved: no air entry any more. Bypass surgery was started without further problem. Reference complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20428656]
(b)(4). The sample was not returned to the manufacturer and hence no evaluation was performed. Reference complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00496 |
| MDR Report Key | 4945017 |
| Report Source | 01,05,06 |
| Date Received | 2015-07-28 |
| Date of Report | 2014-12-16 |
| Date of Event | 2014-12-16 |
| Date Facility Aware | 2014-12-16 |
| Report Date | 2014-12-16 |
| Date Reported to Mfgr | 2014-12-16 |
| Date Mfgr Received | 2014-12-16 |
| 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 |
| 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 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 |
| Model Number | VHK 71000 |
| Catalog Number | 70106.3805 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 |