Model Number 180343 |
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. .
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Event Description
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During a customer experience survey a patient reported that their peritoneal dialysis (pd) catheter got blocked following a hernia surgery and they had the catheter removed.Additional information was requested, however to date has not been provided.
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Event Description
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During a customer experience survey a patient reported that their peritoneal dialysis (pd) catheter got blocked following a hernia surgery and they had the catheter removed.Additional information was requested, however to date has not been provided.
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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.Should additional relevant information become available, a supplemental report will be submitted. .
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Manufacturer Narrative
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Additional information: h10 (clinical investigation) clinical investigation: there is a possible temporal relationship between pd therapy utilizing the fresenius cycler and the patient event of hernia.However, it is unknown if this anonymous patient was utilizing fresenius product(s) at the time their reported hernia event occurred.Furthermore, there is no documentation in the complaint file to show a causal relationship between the hernia event and use of the fresenius cycler.Additionally, there is no allegation of a device malfunction or deficiency, or defect reported for the event.All patients on pd modality are at risk of hernia due to increased intra-abdominal pressure from the dialysate used during the normal physiological process of peritoneal dialysis therapy, as well as a weakened abdominal wall muscle made from an incision for placement of a pd catheter.Based on the limited information, with no allegation of a device malfunction, deficiency or defect and no confirmation that any fresenius product(s) were utilized, the fresenius cycler can be excluded as the cause of the patient¿s reported hernia event.
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Event Description
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During a customer experience survey a patient reported that their peritoneal dialysis (pd) catheter got blocked following a hernia surgery and they had the catheter removed.Additional information was requested, however to date has not been provided.
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Search Alerts/Recalls
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