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 04/09/2024 |
Event Type
malfunction
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Event Description
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A peritoneal dialysis (pd) patient's spouse reported that there was a fluid leak during the patient's pd treatment.There were first three air detected in cassette warnings during drain zero, but then during fill 1 fluid was noticed leaking from the connector to the patient line.The patient reset up with new supplies.Attempts to gather additional missing details were not successful.There was no reported harm during the initial report.A sample has not been returned.
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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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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 spouse reported that there was a fluid leak during the patient's pd treatment.There were first three air detected in cassette warnings during drain zero, but then during fill 1 fluid was noticed leaking from the connector to the patient line.The patient reset up with new supplies.Attempts to gather additional missing details were not successful.There was no reported harm during the initial report.A sample has not been returned.
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Search Alerts/Recalls
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