MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-03 for TRANSDUCER PROTECTOR 0493072 manufactured by Gelman Sciences.
[15791]
Transducer protector leaked, causing a backup of blood that filled the transducer line and saturated the transducer. Rn reports they were unable to lower the drip chamber level and start the blood pump. The pt's dialyzer clotted; treatment stopped and restarted with dialyzer and lines.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243621-1995-00264 |
| MDR Report Key | 21860 |
| Date Received | 1995-04-03 |
| Date of Report | 1995-03-30 |
| Date of Event | 1995-03-16 |
| Date Facility Aware | 1995-03-27 |
| Report Date | 1995-03-30 |
| Date Reported to FDA | 1995-03-30 |
| Date Reported to Mfgr | 1995-03-30 |
| Date Added to Maude | 1995-05-19 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSDUCER PROTECTOR |
| Generic Name | TRANSDUCER PROTECTOR |
| Product Code | FIB |
| Date Received | 1995-04-03 |
| Catalog Number | 0493072 |
| Lot Number | 1413 |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21921 |
| Manufacturer | GELMAN SCIENCES |
| Manufacturer Address | 600 S WAYNE BLVD ANN ARBOR MI 48106 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-04-03 |