CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number RTLR180343 |
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 08/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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Clinical review: based on the information available, the liberty select cycler is disassociated from the event, as there is no allegation or objective evidence indicating a product deficiency or malfunction caused or contributed to the adverse event(s).Furthermore, to our knowledge, the patient continues to utilize the same liberty select cycler without any reported issues or allegations of machine malfunction or deficiency.Therefore, the completion of a clinical investigation is not warranted at this time.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 peritoneal dialysis (pd) patient contacted technical support for assistance with an issue that occurred during step 1 of set up.The patient was not connected.The patient was at the hospital and wanted the phone number of their personal peritoneal dialysis registered nurse (pdrn) so that they could assist the hospital nurse in setting up the hospital cycler.Upon follow up with the health services facility, no record or information regarding the patient could be found.Multiple attempts have been made requesting additional information, however to date have not been received.
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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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