MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06,07 report with the FDA on 2015-07-28 for RESERVOIR VHK manufactured by Maquet Cardiopulmonary Ag.
[6196225]
The product was investigated under complaint# (b)(4) and an additional failure was found as follows: "blue piece of plastic were detected in the oxygenator". This additional complaint was opened in order to cover this failure. Ref. #: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13708810]
During investigation of a complaint, an additional malfunction was found. This additional complaint was opened in order to cover the failure. Maquet cardiopulmonary (b)(4) is aware of similar complaints showing a similar malfunction. Most probable root cause is that the blue pieces come from the connected reservoir (welding points). Due to this no further action will be completed at this time. This data is being handled through a designated maquet cardiopulmonary tracking and trending process. Abbreviation nc: nonconformance. Additional info: the product mentioned is a tubing set with reservoir and the included affected component has the contributing design function of the reservoir which is registered under 510 (k): k102919.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00841 |
| MDR Report Key | 4951757 |
| Report Source | 00,01,05,06,07 |
| Date Received | 2015-07-28 |
| Date of Report | 2015-07-24 |
| Date of Event | 2015-07-24 |
| Date Mfgr Received | 2015-07-24 |
| Date Added to Maude | 2015-07-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 29321132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESERVOIR VHK |
| Product Code | DTN |
| Date Received | 2015-07-28 |
| 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 | 2015-07-28 |