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Catalog Number 5C8310 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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A peritoneal dialysis (pd) patient experienced an unspecified sentinel event while connected to the homechoice device.The event occurred while the patient was hospitalized for an unspecified condition.The sentinel event was not further described.The cause of the event, treatment details, action taken with pd therapy, and the patient¿s recovery status were not reported.No additional information is available.
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Manufacturer Narrative
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Additional information: device available for evaluation?, device evaluated by mfr?, evaluation codes, additional mfr narrative.The device was received for evaluation.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A device history review revealed no issues that could have caused or contributed to the reported issue.An internal and external inspection was performed and no issues were noted.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional and electrical testing of the device.The device was determined to meet functional and electrical performance specification requirements per rite testing.The reported issue could not be verified through the device evaluation.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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