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 2015-04-16 for QUADROX-I NEO. MIT RESERVOIR 70105.0109 VKMO 10000 manufactured by Maquet Cardiopulmonary Ag.
[19503202]
It was reported that the perfusionist found the de-airing valve broken just after he finished priming. There was no intense knock on it. And he stopped and exchanged. No consequences to the pt were reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19521818]
Maquet cardiopulmonary received the provided complaint description and additionally a picture of the product in question. However, the damage visable on the picture is not concurring with the provided info. Additional info is requested. A supplemental report will be provided if new info becomes available. Additional info: the product mentioned is not distributed to the us, but the product with contributing design function to the affected component (qu adrox-i neonatal) is registered under 510 (k): k102464.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00378 |
| MDR Report Key | 4706435 |
| Report Source | 00,01,05,06,07 |
| Date Received | 2015-04-16 |
| Date of Report | 2015-03-17 |
| Date of Event | 2015-02-14 |
| Date Mfgr Received | 2015-03-17 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2015-06-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT |
| Manufacturer Country | GM |
| Manufacturer Phone | 2229321132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUADROX-I NEO. MIT RESERVOIR |
| Product Code | DTN |
| Date Received | 2015-04-16 |
| Model Number | 70105.0109 |
| Catalog Number | VKMO 10000 |
| Lot Number | 92125116 |
| Device Expiration Date | 2016-04-01 |
| 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 | 2015-04-16 |