Catalog Number RTLR180343 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Information (3190)
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Event Date 11/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Clinical review: based on the limited information available, the liberty select cycler is disassociated from the event(s), as there is no allegation or objective evidence indicating a fresenius product deficiency or malfunction caused or contributed to the patient¿s hospitalization or a serious adverse event.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 patient on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy was hospitalized for a few weeks.The duration, cause, and treatment details of the hospitalization are unknown.Additional information was requested, however to date has not been provided.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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