FDA Adverse Event
Malfunction
Summary report: N
MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP
MDR report key: 1061047
·
Received June 12, 2008
Report
- Report Number
- 1423500-2008-00488
- Event Type
- Malfunction
- Date Received
- June 12, 2008
- Date of Event
- May 24, 2008
- Report Date
- May 24, 2008
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- KDJ
- PMA / PMN Number
- K883239
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER THE DIALYSIS NURSE, THE TRANSFER SET WAS RE-ATTACHED AND IS UNAVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BAXTER REGARDING THEIR TRANSFER SET SEPARATING FROM THEIR PATIENT LINE DURING THERAPY. THROUGH INVESTIGATION, IT WAS DISCOVERED THAT THE SEPARATION OCCURRED AT THE TRANSFER SET/CATHETER ADAPTER INTERFACE. THE PATIENT'S NURSE STATED THAT THE TRANSFER SET WAS RE-ATTACHED, AND THAT THE PATIENT WAS GIVEN ANTIBIOTICS AS A PRECAUTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP | TRANSFER SET/78KDJ | KDJ | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |