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 10/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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Clinical review: based on the available information, there is no allegation or indication that a fresenius device or product issue caused or contributed to a serious patient harm or injury.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 on peritoneal dialysis (pd) was hospitalized on (b)(6) 2020 through (b)(6) 2020 for heart issues.There were no reported allegations that the hospitalization was related to pd therapy or any issues with a fresenius device, or product.Additional information was requested, however 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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