FDA Adverse Event
Injury
Summary report: N
VENOUS BLOODLINE FOR FRESENIUS 2008
MDR report key: 292235
·
Received August 22, 2000
Report
- Report Number
- 8030665-2000-00267
- Event Type
- Injury
- Date Received
- August 22, 2000
- Date of Event
- July 29, 2000
- Report Date
- August 22, 2000
- Manufacturer
- ERIKA DE REYNOSA
- Product Code
- FKJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
FACILITY REPORTED THAT WHEN THE "PCT" INCREASED THE BLOOD PUMP SPEED, THE BLOOD LINE DISCONNECTED FROM THE TESIO CATHETER. ESTIMATED BLOOD LOSS 250CC. NO ADVERSE EFFECT TO THE PT. NO MEDICAL INTERVENTION. THE "PCT" RECONNECTED THE LINE TO THE CATHETER AND THE TREATMENT FINISHED WITHOUT FURTHER INCIDENT. MEDWATCH FILED ON THE BLOOD LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENOUS BLOODLINE FOR FRESENIUS 2008 | HEMODIALYSIS BLOOD LINE | FKJ | ERIKA DE REYNOSA | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Other | TESIO CATHETER, 2008H DIALYSIS MACHINE 7/29/2000. |