Catalog Number 114746 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/29/2021 |
Event Type
Injury
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Event Description
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It was reported that during treatment with a revaclear 400, an internal blood was observed.The blood was not returned to the patient and approximately 250ml of blood was lost.Due to low blood percentage, a blood transfusion was provided to compensate for the blood that was not returned.No additional information is available.
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Manufacturer Narrative
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(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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The actual device and photographs were received for evaluation.Visual inspection of the two provided photos showed the product after treatment.Blood was visible on the dialysate side.Visual of the actual sample with the naked eye of the actual sample showed that the product was heavily contaminated with blood.After the disinfection a leakage test of blood side was performed which showed a leakage in the header area.Visual inspection by microscope shows a twisted o-ring sealing.The reported condition was verified.The cause of the condition was determined to be a manufacturing issue.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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