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 Problems
Dehydration (1807); Vomiting (2144)
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Event Date 11/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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Clinical statement: 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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It was reported that a patient was dehydrated to the point of throwing up and was admitted to the hospital for a week.Upon follow up, the patient¿s peritoneal dialysis registered nurse (pdrn) reported the patient¿s hospitalization was unrelated to any fresenius products, or the liberty select cycler.According to the pdrn, the patient had recently started pd therapy and was having a tough time adjusting.No further information was provided related to the cause of the patient¿s hospitalization.The pdrn stated the patient is fine now and doing well.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.
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Event Description
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It was reported that a patient was dehydrated to the point of throwing up and was admitted to the hospital for a week.Upon follow up, the patient¿s peritoneal dialysis registered nurse (pdrn) reported the patient¿s hospitalization was unrelated to any fresenius products, or the liberty select cycler.According to the pdrn, the patient had recently started pd therapy and was having a tough time adjusting.No further information was provided related to the cause of the patient¿s hospitalization.The pdrn stated the patient is fine now and doing well.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.
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Manufacturer Narrative
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Correction: h4 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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