MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06 report with the FDA on 2015-03-17 for VKMO 31000#QUADROX-I PAD. MIT RESERVOIR 70104.9185 manufactured by Maquet Cardiopulmonary Ag.
[5592479]
It was reported there was leakage on the purge line. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13082504]
The device has been received. Device evaluation anticipated, but not yet begun. Maquet cardiopulmonary is aware of similar complaints for this product and an internal process ((b)(4)) was initiated to determine the most probable root-cause and implement the appropriate corrective action. A supplemental medwatch will be submitted when additional information is received. Abbreviation mrb: material review board.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00249 |
| MDR Report Key | 4619139 |
| Report Source | 00,01,06 |
| Date Received | 2015-03-17 |
| Date of Report | 2015-02-16 |
| Date of Event | 2015-02-16 |
| Date Mfgr Received | 2015-02-16 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2015-05-04 |
| 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 STRABE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 2229321132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VKMO 31000#QUADROX-I PAD. MIT RESERVOIR |
| Generic Name | VKMO |
| Product Code | DTN |
| Date Received | 2015-03-17 |
| Returned To Mfg | 2015-03-05 |
| Catalog Number | 70104.9185 |
| Lot Number | 92114458 |
| Device Expiration Date | 2016-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-17 |