ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Model Number LIBERTY CYCLER SET, DUAL PATIENT CONNECT |
Device Problems
Fluid/Blood Leak (1250); Hole In Material (1293)
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Patient Problems
Abdominal Pain (1685); Fever (1858); Peritonitis (2252)
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Event Date 05/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A temporal relationship exists between the liberty select cycler, liberty cycler set and the reported adverse event(s) of fever, abdominal pain and subsequent diagnosis of peritonitis which required outpatient antibiotic therapy.The etiology of the event(s) of fever, abdominal pain and peritonitis cannot fully be appreciated at this time.However, the fever and abdominal pain were likely an early symptom of the underlying peritonitis.The product investigation, although unable to reproduce a malfunction, did note dried dialysate in the cassette housing.The product investigation regarding the liberty cycler set is still pending at the time of this clinical investigation.Due to a likely breach in sterility during ccpd therapy, a possible causal relationship cannot be ruled out.A supplemental report will be submitted upon completion of the plant¿s investigation.
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Event Description
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During a follow-up call on (b)(6) 2018 the peritoneal dialysis nurse (pdrn) reported the patient was training at the outpatient dialysis clinic, when the patient had to leave emergently for an appointment (details unknown).While the pdrn was breaking down the cycler, fluid (suspected dialysate) was noted in the cassette housing causing ¿everything to be wet.¿ the pdrn stated no alarms were encountered during pd therapy.A pd effluent fluid culture and cell count were collected on (b)(6) 2018 following the event(s).The culture results revealed no growth; however, the cell count showed an elevated white blood cell (wbc) count of 187.The patient was treated outpatient with intraperitoneal (ip) vancomycin 2g (frequency and duration unknown) and ip tobramycin 160mg (frequency and duration unknown).The pdrn reported the patient transitioned to in-center hemodialysis (hd) while the peritonitis was being treated and has since returned to home based ccpd therapy on (b)(6) 2018.
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Manufacturer Narrative
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The manufacturing plant received the alleged sample on 05/16/2018, code 050-87212, without its original package.During disinfection the alleged failure was confirmed, a leak was found on the cassette film.A visual inspection was performed to sample cassette and noticed a pin hole at the cassette film.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.
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Event Description
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Search Alerts/Recalls
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