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 2015-02-23 for VKMO 70000 #QUADROX-I HMO 70000+VHK71 70106.4523 manufactured by Maquet Cardiopulmonary Ag.
[5526750]
It was reported that after priming, continuous air was in the venous line. The leakage was noted in the reservoir venous inlet port in the temperature probe. Leakage repair, checked again, ok. No reported patient effect. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12948325]
The device has not been returned for evaluation. Additional info: the product mentioned under section d 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. A supplemental medwatch will be submitted if additional info becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00110 |
| MDR Report Key | 4550627 |
| Report Source | 01,05,06 |
| Date Received | 2015-02-23 |
| Date of Report | 2014-12-15 |
| Date of Event | 2014-12-13 |
| Date Mfgr Received | 2014-12-29 |
| Date Added to Maude | 2015-03-26 |
| 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 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 70000 #QUADROX-I HMO 70000+VHK71 |
| Generic Name | RESERVOIR |
| Product Code | DTN |
| Date Received | 2015-02-23 |
| Model Number | 70106.4523 |
| Catalog Number | 70106.4523 |
| Lot Number | 92138699 |
| Device Expiration Date | 2016-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-02-23 |