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 Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2024 |
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 reported that there was a fluid leak during pd treatment.When the cassette was removed there was fluid on the sensor.In a follow up, a pd nurse verified the event and said the fluid was discovered upon treatment completion when the patient was removing the cycler set from the cassette compartment of the liberty select cycler.The patient inspected the cycler set.No defect or damage was noted.Adrina stated that the patient was prescribed prophylactic antibiotic ciprofloxacin (250 mg, oral, three times daily for three days).Adrina confirmed that despite the prophylactic antibiotics, there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.Adrina confirmed the cycler remained with the patient for continued use.The patient dried out the cassette compartment of the cycler and planned to continue using.The cassette is available to return as a sample.
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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 reported that there was a fluid leak during pd treatment.When the cassette was removed there was fluid on the sensor.In a follow up, a pd nurse verified the event and said the fluid was discovered upon treatment completion when the patient was removing the cycler set from the cassette compartment of the liberty select cycler.The patient inspected the cycler set.No defect or damage was noted.Adrina stated that the patient was prescribed prophylactic antibiotic ciprofloxacin (250 mg, oral, three times daily for three days).Adrina confirmed that despite the prophylactic antibiotics, there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.Adrina confirmed the cycler remained with the patient for continued use.The patient dried out the cassette compartment of the cycler and planned to continue using.The cassette is available to return as a sample.
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Search Alerts/Recalls
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