Catalog Number RTLR180343 |
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 is available to return.
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Manufacturer Narrative
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Additional information: d.9.,h.3.Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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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 is available to return.
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Search Alerts/Recalls
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