FDA Adverse Event
Malfunction
Summary report: N
VENOUS BLOODLINE FOR FRESENIUS 2008
MDR report key: 287696
·
Received July 25, 2000
Report
- Report Number
- 8030665-2000-00222
- Event Type
- Malfunction
- Date Received
- July 25, 2000
- Date of Event
- June 27, 2000
- Report Date
- June 29, 2000
- Manufacturer
- ERIKA DE REYNOSA
- Product Code
- FKJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
A PT WITH AN IMMATURE FISTULA WAS HOOKED UP TO THEIR VASCATH CATHETER. THE CATHETER WAS IMPLANTED IN 2000. A DISCONNECT FROM THE VENOUS LINE WAS NOTED 5-10 MINUTES INTO TREATMENT. EBL<100CC, NO ADDITIONAL PT ADVERSE EFFECTS. THE CLINIC WAS USING THE 2008H MACHINE WITH NARROW LIMITS SOFTWARE BUT THIS WAS NOT TURNED ON. THE MACHINE DID ALARM. THE SAMPLE WAS SAVED FOR EVAL. FOLLOW-UP WITH CLINIC NEEDED. MDR FILED DUE TO BLOODLOSS ONLY. THE PT CARE TECH WAS BELIEVED TO NOT CONNECT THE LINE TIGHTLY. THE EMPLOYEE WAS COUNSELED AND RETRAINING WAS PERFORMED AT THE CLINIC AS PART OF THE CORRECTIVE ACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENOUS BLOODLINE FOR FRESENIUS 2008 | BLOODLINE TUBING FOR HEMODIALYSIS | FKJ | ERIKA DE REYNOSA | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other | 2. VASCATH CATHETER.| 1. 2008H WITH NARROW LIMITS SOFTWARE, |