FDA Adverse Event
Malfunction
Summary report: N
VENOUS BLOODLINE FOR FRESENIUS 2008
MDR report key: 294364
·
Received August 31, 2000
Report
- Report Number
- 8030665-2000-00273
- Event Type
- Malfunction
- Date Received
- August 31, 2000
- Date of Event
- August 24, 2000
- Report Date
- August 30, 2000
- Manufacturer
- ERIKA DE REYNOSA
- Product Code
- FKJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
FACILITY REPORTED A VENOUS LINE DISCONNECT FROM A VASCATH CATHETER 15 TO 20 MINUTES INTO THE TREATMENT. "THE PT IS EXTREMELY RAMBUNCTIOUS" AND THE FACILITY FELT THAT THE PT HAD DISCONNECTED THE LINE. THE LINE WAS RECONNECTED AND THE TREATMENT WAS FINISHED WITHOUT FURTHER INCIDENT. ESTIMATED BLOOD LOSS 50CC. NO MEDICAL INTERVENTION. SAMPLE IS NOT AVAILABLE FOR EXAMINATION. MEDWATCH FILED ON THE BLOOD LOSS. CLINICAL SERVICES AWARE OF THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENOUS BLOODLINE FOR FRESENIUS 2008 | HEMODIALYSIS BLOODLINE | FKJ | ERIKA DE REYNOSA | NA | 0HR022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other | 2008H DIALYSIS MACHINE, VASCATH CATHETER, 8/24/00 |