ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number 050-87216 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Peritonitis (2252)
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Event Date 02/20/2024 |
Event Type
Injury
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Event Description
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A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] was hospitalized due to peritonitis.No additional information was provided during intake.During follow-up, the patient¿s pd registered nurse (pdrn) reported the patient presented to the emergency room on (b)(6) 2024 with complaints of abdominal pain.A peritoneal effluent fluid culture and cell count (wbc elevated, results unavailable) were collected, and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) cefepime 1500 mg daily, and vancomycin 1500 mg every three days for 21 days.However, on (b)(6) 2024, the patient¿s peritoneal effluent culture result returned positive for staphylococcus aureus, and the patient¿s cefepime was discontinued.The patient was discharged on (b)(6) 2024 and has recovered from the serious adverse events.The patient continued to undergo ccpd therapy while hospitalized and resumed utilizing the same liberty select cycler at home without reported issue.The pdrn attributed causality to a touch contamination event, as the patient admitted he occasionally does not perform hand hygiene prior to initiating and/or terminating treatment.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.
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Manufacturer Narrative
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Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty cycler set and the serious adverse events of peritonitis (characterized by abdominal pain), which warranted hospitalization and antibiotic therapy.The pdrn attributed causality to a touch contamination event, as the patient admitted he occasionally does not perform hand hygiene prior to initiating and/or terminating treatment.Per the pdrn, the serious adverse events were unrelated to the patient¿s utilization of a fresenius device(s) and/or product(s).Staphylococcus aureus is commonly found in the mucus membranes and skin of humans and is the most frequent organism associated with peritoneal infections in pd patients.The liberty cycler set can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.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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