CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Model Number 180343 |
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 12/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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Clinical review: the reason for the patient's hospitalization is unknown; however, there is no documentation that it was related to the use of the liberty select cycler, pd therapy or other fresenius product(s).Additionally, there is no allegation of a device malfunction or deficiency reported for the hospitalization event.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.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 contact for a peritoneal dialysis (pd) patient reported to fresenius technical support that the patient was just released from the hospital.Details surrounding the patient's hospitalization, including cause, event date, and treatment course, was not provided.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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