MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-31 for THE BETTER-BLADDER BB14 manufactured by Circulatory Technology Inc..
[41958008]
Bladder decompression was noted during day 7 of pediatric ecmo run. Air was removed from the bladder, patient was repositioned and volume was administered. However, continued decompression was observed. Upon closer inspection, an air leak was discovered at the bottom casing where the tubing meets the hard plastic casing. Bone wax placed over the area and the issue was temporarily resolved. The better-bladder was subsequently replaced in the circuit. The patient was unharmed because the problem was identified and corrected. The occurrence created an unsafe situation that could had led to significant patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061464 |
| MDR Report Key | 5546879 |
| Date Received | 2016-03-31 |
| Date of Report | 2015-08-07 |
| Date of Event | 2015-08-07 |
| Date Added to Maude | 2016-04-05 |
| 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 | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
| Product Code | DTN |
| Date Received | 2016-03-31 |
| Catalog Number | BB14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CIRCULATORY TECHNOLOGY INC. |
| Manufacturer Address | OYSTYER BAY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-31 |