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 2015-03-04 for BO-HQV #70600ADULT PACK BO-HQV 70600 70104.5308 manufactured by Maquet Cardiopulmonary Ag.
[5339254]
It was reported that during use, the temperature probe at the venous inlet was not tight. Air was constantly being sucked into the venous reservoir. The temperature probe was removed and replaced with a plug from the top of the reservoir. This did not solve the problem. The female luer lock in which the probe is inserted is believed to be the problem. No reported pt effect. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13125461]
A follow up medwatch will be submitted when additional info becomes available. 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 | 8010762-2015-00240 |
| MDR Report Key | 4580948 |
| Report Source | 01,05,06 |
| Date Received | 2015-03-04 |
| Date of Report | 2015-02-05 |
| Date of Event | 2015-02-04 |
| Date Mfgr Received | 2015-02-05 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2015-03-10 |
| 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 | BO-HQV #70600ADULT PACK |
| Generic Name | RESERVOIR |
| Product Code | DTN |
| Date Received | 2015-03-04 |
| Model Number | BO-HQV 70600 |
| Catalog Number | 70104.5308 |
| Lot Number | 92119899 |
| Device Expiration Date | 2015-10-01 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Other | 2015-03-04 |