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 Problems
Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
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Patient Problem
Peritonitis (2252)
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Event Date 07/08/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned to the manufacturer for physical evaluation, and the lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer over the past 3 months.The entire set of lots have been sold and distributed.Batch records for the lots identified were reviewed and confirmed there were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.
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Event Description
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A peritoneal dialysis patient's contact reported the patient had drain complications with the cycler.There was a significant amount of fibrin in the patient's effluent.The contact was advised to consult with the patient's nurse to resolve the fibrin.On (b)(6) 2017 a response was received from the clinic reporting the patient had peritonitis as a contributing factor of the event.The patient's catheter was blocked due to fibrin.The patient's nurse reported the patient was not hospitalized for peritonitis.The patient was treated with antibiotics vancomycin and ceftazidime.The peritoneal effluent culture was positive for stenotrophomonas maltophilia.Per the nurse, the source of infection is believed to be from touch contamination.The patient was continuing peritoneal dialysis therapy.
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