MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-31 for GELMAN PRESSURE TRANSDUCER PROTECTOR 20-DTP20 08-2--2 (DISTRIBUTOR #) manufactured by Gelman Sciences, Inc..
[15752]
Four dialysis pts at a clinic became infected with hepatitis. Rn suspects failure of transducer protectors. All pts used same hemodialysis machine. Blood found inside internal pressure transducer protector of the level detector module. Rn said they have experienced many t. P's backing up with blood but are unaware of any incidents of actual ruptured t. P. Membranes. Three other machine were found with blood inside the internal t. P.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-1994-00001 |
| MDR Report Key | 22806 |
| Date Received | 1994-08-31 |
| Date of Report | 1994-08-16 |
| Date Facility Aware | 1994-08-12 |
| Report Date | 1994-08-16 |
| Date Reported to FDA | 1994-08-17 |
| Date Reported to Mfgr | 1994-08-17 |
| Date Added to Maude | 1995-06-26 |
| 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 | GELMAN PRESSURE TRANSDUCER PROTECTOR |
| Generic Name | TRANSDUCER PROTECTOR |
| Product Code | FIB |
| Date Received | 1994-08-31 |
| Model Number | 20-DTP20 |
| Catalog Number | 08-2--2 (DISTRIBUTOR #) |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 23027 |
| Manufacturer | GELMAN SCIENCES, INC. |
| Manufacturer Address | 600 SO. WAGNER ROAD ANN ARBOR MI 48106 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-08-31 |