MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-27 for BIGGER BETTER BLADDER BBB38 manufactured by Circulatory Technology Inc..
[48214725]
Patient Sequence No: 1, Text Type: N, H10
[48214726]
Pump began alarming with an acute high negative bladder pressure of >-100 and pump was alarming. It was noted the better bladder was sucked into itself with very little blood in it. A 1. 1l volume was given to the pt and bladder remained concave. Air was aspirated from the hard shell case that encases the bladder in an attempt to expand it. It took approximately 240ml of air aspiration to get the bladder to open up. There was no air in the actual circuit. Pump began running at a higher flow but bladder continued to collapse multiple times. It was later determined there was a crack in the hard shell that was allowing air to be sucked in around the bladder. The leak was in a seam back to the inter chamber and outer housing. This caused the bladder to collapse. Manufacturer response for ecmo bladder, bigger better bladder (per site reporter): the manufacturer is in touch with a member of the fda and hospital staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5750582 |
| MDR Report Key | 5750582 |
| Date Received | 2016-06-27 |
| Date of Report | 2016-06-15 |
| Date of Event | 2016-05-15 |
| Report Date | 2016-06-15 |
| Date Reported to FDA | 2016-06-15 |
| Date Reported to Mfgr | 2016-06-15 |
| Date Added to Maude | 2016-06-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | BIGGER BETTER BLADDER |
| Generic Name | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
| Product Code | DTN |
| Date Received | 2016-06-27 |
| Model Number | BBB38 |
| Catalog Number | BBB38 |
| Lot Number | 014603 |
| Device Expiration Date | 2016-08-26 |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIRCULATORY TECHNOLOGY INC. |
| Manufacturer Address | 21 SINGWORTH ST. OYSTER BAY NY 11771 US 11771 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-27 |