ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Model Number LIBERTY CYCLER SET |
Device Problems
Fluid/Blood Leak (1250); Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental mdr will be submitted upon device evaluation.
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Event Description
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A peritoneal dialysis patient reported experiencing a leak during drain zero and having switched bags during the treatment, however the leak continued.The fluid leaked onto the cycler.The cause of the leak is unknown.The patient was advised to discontinue the use of their cycler.Upon follow up, the peritoneal dialysis nurse (pdrn) stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and confirmed that the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd).The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient has received a new cycler which is working well and is continuing peritoneal dialysis therapy with no further issues.The cassette used by the patient was discarded and is not available for return for physical evaluation by the manufacturer.
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Manufacturer Narrative
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Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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