Catalog Number 050-50758 |
Device Problems
Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The plant investigation is in progress.A supplemental medwatch report will be submitted upon completion of this activity.
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Event Description
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It was reported that a patient discovered a fluid leak during peritoneal dialysis therapy.The leak was further described as the patient noticed fluid leaking from the connection between the patient line of the cassette and the stay safe multi-segment dual connector.There was no report of a cycler alarm that coincided with the fluid leak.It was unknown during which phase of therapy the leak was identified.The cause of the leak was reported to be a loose connection.Upon reporting the leak, the patient was advised to start therapy over using new supplies.There was no patient injury or medical intervention required as a result of the reported leak.The supplies were not available for evaluation.Following the event, the patient was able to continue with peritoneal dialysis therapy without complication.Additional information was requested but was not available.
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Manufacturer Narrative
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Plant investigation: the device was not returned to the manufacturer for physical evaluation and the lot number was not provided.Distribution records were reviewed to identify potential lots of this product shipped to the customer for the three (3) month time frame which immediately preceded the event.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.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.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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