ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number 050-87216 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2024 |
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 during their pd treatment.The patient reported receiving a draining slowly alarm and an air detected in cassette alarm during drain 4 of 5 of treatment.It is unknown at which point in therapy the leak may have begun.Fluid was seen inside the pump module.The cause of the leak is unknown.The patient was assisted with canceling treatment and advised to follow up with their peritoneal dialysis nurse (pdrn).It was reported that an alternate treatment option was available.Upon follow up, the patient contact confirmed the reported event and that fluid poured out of the cycler door once the cassette was removed.The patient contact stated that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient contact stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated the patient was able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The patient contact confirmed that the cycler set was discarded and not available to be 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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Event Description
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It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak during their pd treatment.The patient reported receiving a draining slowly alarm and an air detected in cassette alarm during drain 4 of 5 of treatment.It is unknown at which point in therapy the leak may have begun.Fluid was seen inside the pump module.The cause of the leak is unknown.The patient was assisted with canceling treatment and advised to follow up with their peritoneal dialysis nurse (pdrn).It was reported that an alternate treatment option was available.Upon follow up, the patient contact confirmed the reported event and that fluid poured out of the cycler door once the cassette was removed.The patient contact stated that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient contact stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated the patient was able to complete peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd) in the absence of the cycler.The patient contact confirmed that the cycler set was discarded and not available to be returned to the manufacturer for physical evaluation.
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Search Alerts/Recalls
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