FDA Adverse Event
Malfunction
Summary report: N
LIBERTY CYCLER
MDR report key: 3861118
·
Received April 14, 2014
Report
- Report Number
- 2937457-2014-00568
- Event Type
- Malfunction
- Date Received
- April 14, 2014
- Date of Event
- March 14, 2014
- Report Date
- March 14, 2014
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- FKX
- PMA / PMN Number
- K043363
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.
Description of Event or Problem · 1
A PERITONEAL DIALYSIS NURSE REPORTED THAT THE PT EXPERIENCED AN IIPV. ON (B)(6) 2014, THE PT WAS IN DWELL 4 AND FELT TOO FULL. THE PT BYPASSED TO DRAIN, BUT ONLY DRAINED 21 ML. 0), FILL: DRAIN: 17; 01), 2496, 2789: 2), 2496, 2045; 3), 2496, 1751; 4), 2496, 21. THE PT DISCONNECTED FROM TREATMENT AND MANUALLY DRAINED 4000 ML INTO ONE BAG AND 1000 INTO ANOTHER BAG FOR A TOTAL OF 5000 ML WHICH WAS 200% OVER THE EXPECTED DRAIN VOLUME OF 2500. THE PT REMAINED ASYMPTOMATIC, AND DID NOT REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE OVERFILL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228253 | LIBERTY CYCLER | FKX | FRESENIUS MEDICAL CARE NORTH AMERICA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | PD SOLUTION| LIBERTY TUBING |