FDA Adverse Event
Malfunction
Summary report: N
VENOUS BLOODLINE FOR FRESENIUS 2008
MDR report key: 298367
·
Received September 25, 2000
Report
- Report Number
- 8030665-2000-00282
- Event Type
- Malfunction
- Date Received
- September 25, 2000
- Date of Event
- August 28, 2000
- Report Date
- September 25, 2000
- Manufacturer
- ERIKA DE REYNOSA
- Product Code
- FKJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
INFORMED BY CLINICAL SERVICES THAT A FACILITY REPORTED 30 MINUTES INTO A TREATMENT, THE CATHETER WAS FLUSHED AND SUBSEQUENTLY THE MACHINE ALARMED. IT WAS FOUND TO BE LEAKING AROUND THE CONNECTION. THE LINE WAS RECONNECTED AND THERE WERE NO FURTHER PROBLEMS. ESTIMATED BLOOD LOSS 50 CC. NO MEDICAL INTERVENTION. THE LINE IS NOT AVAILABLE FOR EXAMINATION. MEDWATCH FILED ON THE BLOOD LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENOUS BLOODLINE FOR FRESENIUS 2008 | HEMODIALYSIS VENOUS BLOODLINE | FKJ | ERIKA DE REYNOSA | NA | 9PR092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Other | 2008E DIALYSIS MACHINE, TESIO CATHETER, 8/28/2000. |