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 09/01/2020 |
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 investigation: subsequent attempts to obtain additional information (e.G.Discharge summary, patient demographics, medication list, past medical history) have thus far proven unsuccessful.Based on the limited information available, the patient¿s liberty select cycler is disassociated from the event(s).There is no allegation or objective evidence indicating a fresenius product(s) or device(s) deficiency or malfunction caused or contributed to the patient¿s hospitalization.
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Event Description
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It was reported that a peritoneal dialysis (pd) patient was "in the hospital the last few days".No information regarding the hospitalization was provided at intake.Additional information was requested, but 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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