MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-23 for THE BETTER BLADDER BB14 manufactured by Circulatory Technology Inc..
[39263301]
One part, "the better bladder" (mm item (b)(4)), that makes up the ecmo circuit was found to be defective during circuit priming and had to be removed and replaced with a new better bladder. The part had been primed with donor blood but the circuit was not connected to a pt until after the part was replaced. There was no harm to the pt and there was no delay in treatment. Ecmo initiation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060526 |
| MDR Report Key | 5462942 |
| Date Received | 2016-02-23 |
| Date of Report | 2016-02-23 |
| Date of Event | 2016-02-19 |
| Date Added to Maude | 2016-02-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THE BETTER BLADDER |
| Generic Name | ECMO, CIRCUIT BLADDER |
| Product Code | DTN |
| Date Received | 2016-02-23 |
| Catalog Number | BB14 |
| Lot Number | 014882 |
| Device Expiration Date | 2018-09-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIRCULATORY TECHNOLOGY INC. |
| Manufacturer Address | OYSTER BAY NY 11771 US 11771 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-23 |