FDA Adverse Event
Injury
Summary report: N
LIBERTY CYCLER
MDR report key: 3896226
·
Received June 13, 2014
Report
- Report Number
- 2937457-2014-01038
- Event Type
- Injury
- Date Received
- June 13, 2014
- Date of Event
- May 3, 2014
- Report Date
- May 19, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PLANT'S INVESTIGATION.
Description of Event or Problem · 1
A PERITONEAL DIALYSIS (PD) NURSE REPORTED DURING A FOLLOW UP CALL THAT THE PT WAS ADMITTED FOR EXIT SITE TOUCH CONTAMINATION STAPHYLOCOCCUS EPIDERMIS PERITONITIS. THE PT WAS DISCHARGED ON (B)(6) 2014 AND CONTINUED TO BE TREATED WITH ORAL CIRPOFLOXIN 500MG TWICE A DAY AND VANCOMYCIN 1500MG IP FOR THREE DOSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351398 | LIBERTY CYCLER | FKX | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization| R | LIBERTY CYCLER CASSETTE| DELFLEX PD SOLUTIONS |