Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 07/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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Event Description
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A registered nurse (rn) at a user facility reported to post market surveillance (pms) that a patient experienced an infection while undergoing hemodialysis (hd) therapy at a hospital.Additional information has been requested, but has not been made available.There was no allegation that a machine, a dialyzer or bloodline malfunction occurred.No parts were available to be returned to the manufacturer for evaluation.
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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.There were no lot numbers identified that were delivered within this time period.A search was then performed for potential lots that had been distributed to the hospital at the time of the incident and two lots were identified.Batch records for the lots identified were reviewed and confirmed there were no deviations or non-conformance 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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