FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
MDR report key: 2243568
·
Received August 19, 2011
Report
- Report Number
- 8030665-2011-00094
- Event Type
- Malfunction
- Date Received
- August 19, 2011
- Date of Event
- June 14, 2011
- Report Date
- August 17, 2011
- Manufacturer
- REYNOSA MANUFACTURING
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4). OF NOTE: IN ORDER TO EVALUATE THIS COMPLAINT ADDITIONAL INFO WAS REQUIRED AND REQUESTED. THE ADDITIONAL INFO WAS RECEIVED ON (B)(4) 2011.
Description of Event or Problem · 1
A PT HAS REPORTED AN ALARM AND THAN REPORTED A FLUID LEAK AND THAT THE CASSETTE HAD A SMALL HOLE ON THE RIGHT SIDE. THE FLUID LEAK WAS INSIDE THE CASSETTE DOOR. THERE IS NO SAMPLE TO EVALUATE. THERE IS NO REPORT OF PT ILL EFFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIBERTY CYCLER SET, DUAL PATIENT CONNECT | PERITONEAL DIALYSIS TREATMENT TUBING SET | FKX | REYNOSA MANUFACTURING | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | LIBERTY DIALYSIS MACHINE |