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 03/15/2024 |
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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A peritoneal dialysis (pd) patient's contact reported a fluid leak during pd treatment.There was an air detected in cassette warning during drain 3 of treatment.When treatment was stopped fluid was found behind the cassette door on the pump modules.When the patient removed the cassette it was noticed that there was fluid leaking from the cassette.In a follow up, the patient's pd nurse verified that the patient did not have any harm, intervention or adverse event due to the reported leak.The patient was issued a new cycler.The patient is able to do manual treatments and completed treatment on the day of the reported event.The cycler set is not available to return.
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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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A peritoneal dialysis (pd) patient's contact reported a fluid leak during pd treatment.There was an air detected in cassette warning during drain 3 of treatment.When treatment was stopped fluid was found behind the cassette door on the pump modules.When the patient removed the cassette it was noticed that there was fluid leaking from the cassette.In a follow up, the patient's pd nurse verified that the patient did not have any harm, intervention or adverse event due to the reported leak.The patient was issued a new cycler.The patient is able to do manual treatments and completed treatment on the day of the reported event.The cycler set is not available to return.
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