ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Model Number 050-87216 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nausea (1970); Urinary Tract Infection (2120); Peritonitis (2252)
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Event Date 04/20/2023 |
Event Type
Injury
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Event Description
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On (b)(6) 2023 this peritoneal dialysis (pd) patient called fresenius technical support to inquire what to do after discovering lots of fibrin in the patient line.The patient was advised to contact their peritoneal dialysis registered nurse (pdrn).Upon follow-up, the patient stated they were diagnosed with peritonitis.Additional information was provided by the pdrn.On (b)(6) 2023 the patient was feeling nauseated and went to the emergency room (er).The patient was treated for a urinary tract infection (uti) with rocephin (dose, route, frequency, and duration unknown).Additionally, the patient was found to have electrolyte imbalances (low sodium, magnesium, and potassium).The patient was kept in the er overnight and released the next morning once the nausea ceased.The pdrn stated the uti and electrolyte imbalances were unrelated to pd therapy or any fresenius products.The patient was then seen in the pd clinic where pd effluent cultures were obtained.The cultures returned positive for staphylococcus epidermidis.The patient was prescribed intraperitoneal (ip) vancomycin and ceftazidime (dose, frequency, and duration unknown) for the peritonitis episode.The pdrn stated that based on the culture results, touch contamination is the likely cause of the patient¿s peritonitis event.No further information was provided.
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Event Description
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On (b)(6) 2023, this peritoneal dialysis (pd) patient called fresenius technical support to inquire what to do after discovering lots of fibrin in the patient line.The patient was advised to contact their peritoneal dialysis registered nurse (pdrn).Upon follow-up, the patient stated they were diagnosed with peritonitis.Additional information was provided by the pdrn.On (b)(6) 2023, the patient was feeling nauseated and went to the emergency room (er).The patient was treated for a urinary tract infection (uti) with rocephin (dose, route, frequency, and duration unknown).Additionally, the patient was found to have electrolyte imbalances (low sodium, magnesium, and potassium).The patient was kept in the er overnight and released the next morning once the nausea ceased.The pdrn stated the uti and electrolyte imbalances were unrelated to pd therapy or any fresenius products.The patient was then seen in the pd clinic where pd effluent cultures were obtained.The cultures returned positive for staphylococcus epidermidis.The patient was prescribed intraperitoneal (ip) vancomycin and ceftazidime (dose, frequency, and duration unknown) for the peritonitis episode.The pdrn stated that based on the culture results, touch contamination is the likely cause of the patient¿s peritonitis event.No further information was provided.
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