FDA Adverse Event
Malfunction
Summary report: N
VENOUS BLOODLINE NON-MACHINE SPECIFIC
MDR report key: 297991
·
Received September 22, 2000
Report
- Report Number
- 8030665-2000-00278
- Event Type
- Malfunction
- Date Received
- September 22, 2000
- Date of Event
- August 25, 2000
- Report Date
- August 30, 2000
- Manufacturer
- ERIKA DE REYNOSA
- Product Code
- FKJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
VOICE MAIL CLINICAL SERVICES. FACILITY REPORTED THE VENOUS BLOOD LINE DISCONNECTED FROM THE TESIO CATHETER (IMPLANTED 18 MONTHS AGO) 15 MINUTES INTO THE TREATMENT. THE MACHINE DID ALARM. THE LINE AND CATHETER WERE RECONNECTED AND THE TREATMENT COMPLETED WITHOUT FURTHER INTERRUPTION. ESTIMATED BLOOD LOSS 50CC. NO MEDICAL INTERVENTION. THE SAMPLE WAS DISCARDED BY THE FACILITY. MEDWATCH FILED ON THE BLOODLOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENOUS BLOODLINE NON-MACHINE SPECIFIC | HEMODIALYSIS BLOOD LINE | FKJ | ERIKA DE REYNOSA | NA | 0ER198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other | 1. BAXTER 550 DIALYSIS MACHINE,| 2. TESIO CATHETER, 8/25/2000. |