FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
MDR report key: 2934738
·
Received January 23, 2013
Report
- Report Number
- 8030665-2013-00053
- Event Type
- Malfunction
- Date Received
- January 23, 2013
- Date of Event
- November 21, 2012
- Report Date
- December 26, 2012
- Manufacturer
- REYNOSA MANUFACTURING
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
MEDICAL RECORDS WERE REC'D AND REVIEWED BY THE MFR. THE ACTUAL CULTURE REPORTS WERE NOT REC'D.
Description of Event or Problem · 1
ON (B)(6) 2012: THE PT STATED HE IS TAKING ANTIBIOTICS (VANCOMYCIN, FORTAZ AND TAZICEF) FOR PERITONITIS THAT MAY BE RELATED TO A FLUID LEAK INCIDENT THAT OCCURRED ON (B)(6). AT THE TIME OF THE EVENT, HE DID NOT CONTACT TECH SUPPORT TO REPORT THE LEAK BECAUSE HE ONLY NOTICED A FEW DROPLETS OF FLUID INSIDE THE CYCLER AND ON THE BACK OF THE CASSETTE. HE DID HOWEVER, CONTINUE TO USE THE CYCLER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32991 | LIBERTY CYCLER SET, SINGLE CONN./EXT. DL | LIBERTY DIALYSIS CYCLER TUBING | FKX | REYNOSA MANUFACTURING |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention | LIBERTY DIALYSIS CYCLER |