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
Fluid/Blood Leak (1250); Hole In Material (1293)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the plant¿s investigation.
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Event Description
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Peritoneal dialysis patient encountered an air detected in the cassette alarm during fill 1.The treatment was cancelled.The patient observed fluid leak when removing the cassette from the cycler due to a small hole in the back of the tubing set.Follow up with the patient indicated that the patient did not have any signs of infection, their effluent was clear and they were not prescribed any antibiotics.The set may be available for evaluation.
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Manufacturer Narrative
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The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The entire lot has been sold and distributed.However, an investigation of the device manufacturing records was conducted by the manufacturer.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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Search Alerts/Recalls
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