FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER SET, SINGLE CONN/EXT DL
MDR report key: 3202180
·
Received June 28, 2013
Report
- Report Number
- 8030665-2013-00408
- Event Type
- Malfunction
- Date Received
- June 28, 2013
- Date of Event
- June 3, 2013
- Report Date
- June 3, 2013
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCE DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. SEE MDR # 803665-2013-00403.
Description of Event or Problem · 1
PT ALLEGES HE FOUND FLUID IN THE CYCLER AFTER CANCELLING TREATMENT. PD RN STATED THE PT NEEDED NO MEDICAL INTERVENTION. EFFLUENT REMAINS CLEAR. SAMPLE WAS DISCARDED, NOT AVAILABLE FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 296040 | LIBERTY CYCLER SET, SINGLE CONN/EXT DL | FKX | FRESENIUS MEDICAL CARE NORTH AMERICA | 13CR08903 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | LIBERTY CYCLER |