Catalog Number UNKNOWN- LIBERTY CYCLER UL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hernia (2240)
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Event Date 01/01/2020 |
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: a temporal relationship exists between ccpd therapy utilizing an unknown liberty select cycler, and the serious adverse event(s) of a hernia.The definitive cause of the patient¿s ruptured hernia is unknown; therefore, causality cannot firmly be established.While there is no allegation or objective evidence indicating a fresenius product(s) and/or device(s) deficiency or malfunction occurred causing the events, the unknown cycler cannot be excluded from having a possible causal and/or contributory role in the exacerbation of the patient¿s unknown hernia.Limited follow-up information precluded a more comprehensive investigation.Hernias are a well-known potential complication of pd therapy due to increased intra-abdominal pressure created during pd therapy.During therapy, this pressure caused can exacerbate weaknesses in the supporting abdominal wall structures.
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Event Description
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During an anonymous customer experience survey, it was reported that this customer was on peritoneal dialysis (pd) and it ripped out the hernia from their youth and the doctor would not allow them to do pd therapy.There were no recorded issues with a fresenius device, or product in relation to the reported event.Attempts to obtain additional information could not be completed.
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Event Description
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During an anonymous customer experience survey, it was reported that this customer was on peritoneal dialysis (pd) and it ripped out the hernia from their youth and the doctor would not allow them to do pd therapy.There were no recorded issues with a fresenius device, or product in relation to the reported event.Attempts to obtain additional information could not be completed.
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Manufacturer Narrative
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Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
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Search Alerts/Recalls
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