FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
MDR report key: 2210392
·
Received August 8, 2011
Report
- Report Number
- 8030665-2011-00042
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- July 8, 2011
- Report Date
- August 8, 2011
- Manufacturer
- REYNOSA MFG.
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
OF NOTE: IT WAS LEARNED ON (B)(6) 2011 THAT THE PT RECEIVED PROPHYLACTIC ANTIBIOTICS.
Description of Event or Problem · 1
A PERITONEAL DIALYSIS PT REPORTED A CASSETTE LEAK. THE PT RECEIVED ONE PROPHYLACTIC DOSE OF AN ANTIBIOTIC. THE PT CONTINUES TO USE THIS PRODUCT FOR FURTHER DIALYSIS WITHOUT FURTHER INCIDENT. THE SAMPLE IS AVAILABLE FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIBERTY CYCLER SET, SINGLE CONN./EXT. DL | PERITONEAL DIALYSIS TUBING SET | FKX | REYNOSA MFG. | NA | 11DR08091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | LIBERTY DIALYSIS MACHINE |