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
Material Puncture/Hole (1504)
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Patient Problems
Abdominal Pain (1685); Peritonitis (2252)
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Event Date 02/19/2023 |
Event Type
Injury
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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 (<24 hours) and antibiotic therapy.The outpatient cm attributed causality to a hole discovered in a liberty cycler set utilized by the patient the evening prior.Esrd patients undergoing pd therapy (manual or cycler based) for rrt are at high risk for infections of the peritoneum.Based on the information available, the patient¿s liberty cycler set cannot be disassociated from the events.Given the reported leak by the patient, confirmation of the deficiency by the cm, lack of organism, and no manufacturer evaluation/investigation of the suspect product.The liberty cycler set cannot be excluded from having a possible causal and/or contributory role in the serious adverse events.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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A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to peritonitis.Follow-up with the outpatient clinical manager (cm) confirmed the patient presented to the emergency room on (b)(6) 2023 with abdominal pain.A peritoneal effluent fluid culture and cell count (requested, results unavailable) were collected, and the patient was diagnosed with peritonitis.The patient was started on intraperitoneal (ip) vancomycin 2000 mg every 5 days for 21 days, ceftazidime 1000 mg daily for 21 days and was discharged home <24 hours later.The patient resumed ccpd therapy following discharge (same cycler) and is recovering from the events.Causality was attributed to a hole discovered on the patient line of the cycler set the patient utilized on (b)(6) 2023.The cm stated the patient is very adept at performing pd therapy, after performing spouse's pd therapy for years.
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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)] for renal replacement therapy (rrt) was hospitalized due to peritonitis.Follow-up with the outpatient clinical manager (cm) confirmed the patient presented to the emergency room on (b)(6) 2023 with abdominal pain.A peritoneal effluent fluid culture and cell count (requested, results unavailable) were collected, and the patient was diagnosed with peritonitis.The patient was started on intraperitoneal (ip) vancomycin 2000 mg every 5 days for 21 days, ceftazidime 1000 mg daily for 21 days and was discharged home <24 hours later.The patient resumed ccpd therapy following discharge (same cycler) and is recovering from the events.Causality was attributed to a hole discovered on the patient line of the cycler set the patient utilized on (b)(6) 2023.The cm stated the patient is very adept at performing pd therapy, after performing spouse's pd therapy for years.
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Manufacturer Narrative
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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 during the manufacturing process which could be associated with the reported event.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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