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Catalog Number 5C8310 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Myocardial Infarction (1969)
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Event Date 12/11/2015 |
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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It was reported that a patient experienced heart attack coincident with automated peritoneal dialysis (apd) therapy.On the same day, the patient was hospitalized for the event.Treatment was not reported.Five days later, the patient was discharged from the hospital.No further detail regarding the heart attack event was provided.At the time of this report, dianeal therapy was ongoing.No additional information is available.
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Manufacturer Narrative
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(b)(4).The device was not returned for evaluation; however, the serial number of the device was identified.A device history review revealed no issues that could have caused or contributed to the reported issue.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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