CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number RTLR180343 |
Device Problem
Overfill (2404)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/04/2019 |
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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This is a report of a patient who experienced an increased intraperitoneal volume (iipv) event coincident with peritoneal dialysis (pd) therapy.The patient reported receiving a supply bag lines are blocked alarm during dwell 2 of 3 and could not find a cause for the alarm.After restarting the cycler alarmed with power fail recover failed.A review of the patient¿s treatment records identified that the patient drained 4151 ml during drain 1 of treatment.This drain volume is 207% the patient's prescribed fill volume of 2006 ml.As a result of the iipv event, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.Upon follow up with the pdrn, it was confirmed that the patient did not experience any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn stated that the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd).The patient has received a new cycler which is working well and continuing with pd therapy without issue.The cycler was reported to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Additional information: plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed and no discrepancies were observed.An internal inspection of the cycler reveal an insect infestation.The cycler weighed fill volume values were found to be within tolerance.The cycler underwent a system air leak test, load cell verification, and valve actuation testing and was found to meet product specifications.Load cell verification testing was performed with no issues noted.An as-received simulated treatment was performed and completed without failures.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.
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