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 12/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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Plant investigation: 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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Event Description
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A patient with on continuous cyclic peritoneal dialysis for renal replacement therapy reported that they were hospitalized; however, specifics were not provided.The patient stated that ye received an alarm and did not call to troubleshoot, however went to the hospital.The patient stated that the hospital would not discharge them until they received a replacement cycler.Additional information was requested, however to date has not been provided.
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Manufacturer Narrative
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Correction: clinical review: based on the limited information available, the patient¿s liberty select cycler is disassociated from the event.There is no allegation or objective evidence indicating a fresenius product deficiency or malfunction caused or contributed a serious adverse event, or the patient¿s hospitalization.
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Manufacturer Narrative
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Additional information: d10, h3 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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Manufacturer Narrative
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Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.A simulated therapy was initiated and completed on the cycler without complication.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.The cycler passed a safety clamp operation test.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.
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Search Alerts/Recalls
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