MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-26 for TRANSDUCER PROTECTOR-DOUBLE HIP FILTER 9207 04-9207-4 (NMC CATALOG) manufactured by Gelman Scientific.
[18485184]
Approx 4 hrs after initiation of dialysis treatment pt had venous needle dislodge. Blood was noted on floor. Blood pump stopped and lines were clamped. Pt was sleeping at the time and was believed to have jerked his arm while sleeping. Pt arousable then lost consciousness for several seconds. Pt responded to saline bolus and was verbally communicative after the event. Pt transferred to emergency room after event, seen and released. Blood loss was estimated at 500 cc. Dialysis system did not alarm low venous pressure at time of event. However, the venous pressure monitoring transducer protector was noted to be bloody at time of event and may not have been monitoring properly. Facility has been having problems with transducers backing up. Tubing pulled from use and evaluated by technical department. All alarms functioning properly and calibrations verified. Mdr's being done on transducer protector and venous bloodline since it is unclear which is the source of the problem. Pt returned to the dialysis unit 8/8/96 and dialyzed without difficulty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 36173 |
| MDR Report Key | 36173 |
| Date Received | 1996-08-26 |
| Date of Report | 1996-08-12 |
| Date of Event | 1996-08-06 |
| Date Facility Aware | 1996-08-06 |
| Report Date | 1996-08-12 |
| Date Added to Maude | 1996-09-03 |
| Event Key | 0 |
| Report Source Code | User Facility 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-DOUBLE HIP FILTER |
| Generic Name | TRANSDUCER FILTER |
| Product Code | FIB |
| Date Received | 1996-08-26 |
| Model Number | 9207 |
| Catalog Number | 04-9207-4 (NMC CATALOG) |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 37594 |
| Manufacturer | GELMAN SCIENTIFIC |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1996-08-26 |