FDA Adverse Event
Injury
Summary report: N
VENOUS BLOODLINE FOR FRES 2008; GAMBRO-A
MDR report key: 294180
·
Received August 31, 2000
Report
- Report Number
- 8030665-2000-00260
- Event Type
- Injury
- Date Received
- August 31, 2000
- Date of Event
- August 7, 2000
- Report Date
- August 31, 2000
- Manufacturer
- ERIKA DE REYNOSA
- Product Code
- FKJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE REPORTED EVENT WAS A VENOUS BLOODLINE DISCONNECT FROM A TESIO CATHETER AT SECOND HOUR OF TREATMENT. BLOOD LOSS REPORTED AS 300CC. NO VENOUS PRESSURE ALARMS SOUNDED AFTER THE DISCONNECTION. THE RN REPORTED THAT THE CONNECTION "APPEARED TO LOOSEN UP". THERE WERE NO ADVERSE AFFECTS WITH THE PT AND THE INCIDENT, ACCORDING TO THE RN AT THE CLINIC. MEDWATCH FILED ON THE BLOOD LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENOUS BLOODLINE FOR FRES 2008; GAMBRO-A | BLOODLINE TUBING FOR HD | FKJ | ERIKA DE REYNOSA | NA | 0DR105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other | FRESENIUS 2008H W/NVL SOFTWARE/MEDCOMP TESIO| CATHETER PLACED 6/00. |