MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2015-01-16 for HQV 51100# ADULT PRE-CONNECTED PACK 70102.6914 manufactured by Maquet Cardiopulmonary.
[5393167]
It was reported that bypass and the venous line were initiated. A large volume of blood was observed entering the reservoir from the three suckers. Blood was observed exiting from the top of the filter housing of the reservoir. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12852727]
The device has not been received for evaluation. A follow up medwatch will be sent when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[63266135]
The sample is not available for investigation. According to the provided video the failure can be confirmed. Device failure cannot be confirmed. Similar complaints should be observed. For the time being no further investigation will be performed. The data is being handled through a designated maquet cardiopulmonary trending and applicable investigation process. Due to this no further investigation initiations will be completed at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00016 |
| MDR Report Key | 4435846 |
| Report Source | 00,01,05,06 |
| Date Received | 2015-01-16 |
| Date of Report | 2014-12-16 |
| Date of Event | 2014-12-16 |
| Date Mfgr Received | 2014-12-16 |
| Date Added to Maude | 2015-01-22 |
| 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 | 0 |
| 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 | HQV 51100# ADULT PRE-CONNECTED PACK |
| Generic Name | RESERVOIR |
| Product Code | DTN |
| Date Received | 2015-01-16 |
| Model Number | 70102.6914 |
| Lot Number | 92148289 |
| Device Expiration Date | 2016-09-01 |
| 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 |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-16 |