MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-29 for VIRAJECT DIALYSIS TRANSDUCER PROTECTOR manufactured by Terumo Medical Corp..
[18197267]
The device leaked. The device was filled with blood and had to be changed several times during treatment resulting in clotting of the dialyzer and loss of approx 100 cc of blood. Blood also leaked through the device into the pressure transducer which had to be disassembled, cleaned and disinfected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004175 |
| MDR Report Key | 18023 |
| Date Received | 1994-11-29 |
| Date of Report | 1994-11-28 |
| Date Added to Maude | 1994-11-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIRAJECT DIALYSIS TRANSDUCER PROTECTOR |
| Product Code | FIB |
| Date Received | 1994-11-29 |
| Lot Number | 1134 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17951 |
| Manufacturer | TERUMO MEDICAL CORP. |
| Manufacturer Address | SOMERSET NJ 08873 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-11-29 |