MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-09-16 for UNIFUSOR 803FGA manufactured by Cas Medical Systems, Inc. (statcorp).
[1433448]
"the information passed on from the distributor indicates that the device used in the hospital did not maintain its desired inflation pressure for the expected time of use. Gradually decreasing inflation pressure led to the occlusion of a patient's arterial line and resulted in the need to replace the arterial line. There was no adverse effect to the patient. The products gauge t-fitting was identified by visual examination as the source of the leak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2244861-2010-00001 |
| MDR Report Key | 1841305 |
| Report Source | 08 |
| Date Received | 2010-09-16 |
| Date of Report | 2010-09-14 |
| Date of Event | 2010-08-01 |
| Date Mfgr Received | 2010-08-16 |
| Date Added to Maude | 2011-03-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 44 EAST INDUSTRIAL RD. |
| Manufacturer City | BRANFORD CT 06405 |
| Manufacturer Country | US |
| Manufacturer Postal | 06405 |
| Manufacturer Phone | 2034886056 |
| Manufacturer G1 | CAS MEDICAL SYSTEMS, INC. (STATCORP) |
| Manufacturer Street | 14476 DUVAL PLACE WEST |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIFUSOR |
| Generic Name | PRESSURE INFUSOR FOR AN IV BAG |
| Product Code | KZB |
| Date Received | 2010-09-16 |
| Returned To Mfg | 2010-09-01 |
| Model Number | 803FGA |
| Catalog Number | 803FGA |
| Lot Number | UNK |
| ID Number | 17001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAS MEDICAL SYSTEMS, INC. (STATCORP) |
| Manufacturer Address | 14476 DUVAL PLACE WEST JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-09-16 |