ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number 050-87212 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
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Event Description
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It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak on the inside of the cassette door of their cycler after ending their pd treatment.The patient reported receiving a patient line is blocked (soft alarm) prior to the leak.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.The patient was advised to discontinue the use of their cycler and follow up with their peritoneal dialysis nurse (pdrn).A new cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up, the 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 peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.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 available for return for physical evaluation by the manufacturer.The cycler was reported to have been returned to the manufacturer for physical evaluation.
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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.
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