Device product

Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111

Z-0693-2016

December 15, 2015

Class II

Product summary

Firm: Fresenius Medical Care Renal Therapies Group, LLC
Event: Event 72926
Status: Terminated
Classification: Class II
Quantity: 14,094 units
Official record key: device-enforcement:Z-0693-2016

Official wording

Reason: The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).

Code information: All lot numbers

Distribution pattern: Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).