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 07/01/2020 |
Event Type
Injury
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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.Clinical review: 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.Therefore, the completion of a clinical investigation is not warranted at this time.
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Event Description
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The contact for a peritoneal dialysis (pd) patient reported to technical support that a 'patient line (pl) is blocked' alarm occurred during the patient's treatment on the liberty select cycler.During the call it was reported that the patient was just released from the hospital and had been doing continuous ambulatory peritoneal dialysis (capd) during the hospitalization.The reason for the patient's hospitalization was unknown, however; there was no documentation or allegation that the patient was admitted for reasons related to the use of the liberty select cycler or pd therapy.Multiple attempts have been made to obtain additional information, and at this time no additional information has been provided.
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Manufacturer Narrative
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Plant investigation: the device was not 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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