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
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/25/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) - 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 registered nurse stated the patient encountered a fluid intrusion.The patient was prescribed antibiotics; drug name, dose and frequency was not provided.During follow-up with patient¿s nurse she stated the patient was given antibiotics prophylactically and confirmed that the patient did not have an infection.During follow-up with the patient she clarified that she encountered a fluid leak during the treatment.The patient stated the leak occurred at the connection of her catheter and the disposable tubing line.The set was discarded.
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Search Alerts/Recalls
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