Catalog Number RTLR180343 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Constipation (3274)
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Event Date 07/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Clinical investigation: based on the information available, the liberty select cycler is disassociated from the event as there is no allegation or objective evidence indicating a product deficiency or malfunction caused or contributed to the reported hospitalization.Furthermore, the patient continues to utilize the same liberty select cycler without reported issue or allegation of a machine malfunction or deficiency.Therefore, the completion of a clinical investigation is not warranted at this time.Should additional information become available the need for a clinical investigation will be reassessed accordingly.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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It was reported that a peritoneal dialysis (pd) patient was hospitalized for unknown reasons.The patient¿s pd registered nurse (pdrn) indicated they are aware of the patient¿s chronic constipation and would contact the patient to assess and address the catheter function and presence of constipation.Multiple attempts were made to acquire additional information regarding the reported hospitalization and to this date a response has not been received.
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Manufacturer Narrative
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Additional information: corrected information: plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.A post-accelerated stress test (ast) simulated treatment was performed over 2 hours and 15 minutes with 8500ml and completed without issues.The cycler underwent and passed a system air leak test and a valve actuation test.An internal inspection found no discrepancies.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformance 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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Search Alerts/Recalls
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