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
Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/11/2016 |
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 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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Event Description
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The peritoneal dialysis (pd) patient called and stated that last night was the first time she used her replacement cycler and when she removed the cassette there was fluid leaking.Patient stated that there was fluid coming out of the cassette and there was fluid inside the pump module.Follow-up was made with the pd patient's clinic registered nurse (rn), who stated the instance occurred after the patient had completed treatment and was in the process of opening the cassette door.The pdrn stated the patient was requested to come into the clinic to discuss the occurrence and to go over setup processes with the cycler, and stated it was unknown what may have caused the fluid leaks.Per pdrn the patient did not require any medical intervention and no prophylactic medication was required or provided as a result of the reported occurrence.The set was discarded.
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Search Alerts/Recalls
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