Model Number 2008K |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Edema (1820)
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Event Date 01/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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Based on the available information, there is no allegation or documentation that indicates the 2008 k machine caused or contributed to the patient¿s pulmonary edema event.
The alleged event was not confirmed by the manufacturing plant.
The device was not returned to the plant for investigation.
A device history review could not be performed since the lot number is unknown.
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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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Patient (who is currently receiving peritoneal dialysis treatments) medical records received on an unrelated customer experience indicated that the patient was diagnosed and treated for a pulmonary edema on an unknown date.
Follow-up with the patient's nurse indicated that the alleged event occurred sometime in 2016.
The patient was receiving dialysis treatment at an in-center dialysis clinic at the time.
Additional information was solicited.
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Search Alerts/Recalls
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