Catalog Number 109651 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Pain (1994)
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Event Date 12/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter facility name: (b)(6) hospital.Phone number: (b)(6).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 within five minutes of treatment with a polyflux 14l, the patient experienced chest pain and back muscle pain.The treatment was interrupted.Electrocardiogram monitoring and oxygen inhalation was provided to the patient.It was reported that 10 minutes later, the symptoms were relieved, and a new dialyzer (product details not specified) was used to continue the dialysis treatment lasting four hours.No additional information is available.
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Manufacturer Narrative
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Additional information added to h6 and h10 h10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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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