FDA Adverse Event
Injury
Summary report: N
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
MDR report key: 3810664
·
Received April 30, 2014
Report
- Report Number
- 8030665-2014-00340
- Event Type
- Injury
- Date Received
- April 30, 2014
- Date of Event
- April 5, 2014
- Report Date
- April 5, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- 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
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON FINAL REVIEW OF MEDICAL RECORDS BY POST MARKET CLINICAL PHYSICIAN AND COMPLETION OF THE PLANT'S INVESTIGATION.
Description of Event or Problem · 1
A PERITONEAL DIALYSIS (PD) PATIENT REPORTED HE RECEIVED AN ALARM FOR FLUID LEAK DURING TREATMENT. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2014 WITH COMPLAINTS OF SEVERE ABDOMINAL PAIN. CULTURES REVEALED STAPHYLOCOCCUS AUREUS PERITONITIS AND THE PATIENT WAS TREATED WITH VANCOMYCIN. THE PD NURSE CONFIRMED STAPHYLOCOCCUS AUREUS CONTAMINATION PERITONITIS. NO SAMPLES WERE RETAINED FOR INVESTIGATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2014. DURING FOLLOW UP ON (B)(4) 2014 THE PD NURSE STATED THE PATIENT WAS RECOVERING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258639 | LIBERTY CYCLER SET, DUAL PATIENT CONNECT | FKX | FRESENIUS MEDICAL CARE NORTH AMERICA | 13DR08959 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R | LOSARTAN| CALCITROL| SYNTHROID| OMEPRAZOLE| LIBERTY CYCLER, DELFLEX PD SOLUTIONS| RENVELA| POTASSIUM CHLORIDE |