MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2015-08-13 for CARDIOTOMY RESERVOIR VHK 71000 BE-02971#RESERVOIR 70106.3806 manufactured by Maquet Cardiopulmonary Ag.
[23326314]
Maquet cardiopulmonary ag requested the device in question for eval but has it not received yet. A supplemental medwatch will be submitted as soon as add'l info becomes available.
Patient Sequence No: 1, Text Type: N, H10
[23326315]
Customer reported that "foam appeared in the cardiotomy reservoir". No known consequences to the pt. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[68982596]
The sample has been cleaned. A visual inspection has been performed. Thereby it has been detected that the blood outlet connector had cracks. The failure foam in the reservoir could be confirmed due to the pictures and videos sent along with the complaint. Most possible root cause is the leakage (crack in the connector). Dhr: has been reviewed by the supplier and no abnormalities were found. This data will be handled through a designated maquet trending process. If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary. Due to this no further action will be completed at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00885 |
| MDR Report Key | 5006623 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2015-08-13 |
| Date of Report | 2015-08-05 |
| Date of Event | 2011-08-05 |
| Date Mfgr Received | 2015-08-06 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2015-08-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | CARDIOTOMY RESERVOIR VHK 71000 |
| Product Code | DTN |
| Date Received | 2015-08-13 |
| Model Number | BE-02971#RESERVOIR |
| Catalog Number | 70106.3806 |
| Device Expiration Date | 2017-01-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-08-13 |