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 09/25/2020 |
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.Additionally, there is no allegation of a liberty select cycler malfunction or deficiency related to the event.
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Event Description
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A peritoneal dialysis (pd) patient contacted fresenius technical support for a supply bag lines are blocked message.The alarms could not be cleared.During the call, the patient stated they could do manual drains and fill with antibiotics.No further information was provided.Attempts to obtain additional information were unsuccessful.The reason for the patient¿s use of antibiotics is unknown; however, there is no allegation of a device malfunction or deficiency that is related to the antibiotic use.In addition, there was no indication that the use of any fresenius product(s) may have caused or contributed to an adverse event or serious injury.The patient's liberty select cycler remains in their possession and is not expected to be returned for evaluation.
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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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