Catalog Number SL-2000M2095 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 07/17/2015 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is ongoing at the time of this report.Return of the product is anticipated but has not been received to date.Upon completion of the evaluation, a supplemental report will be submitted.
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Event Description
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A report was received on july 23, 2015 regarding a patient who experienced a 250ml blood loss during treatment.During the first 30 minute check, blood was noted to be leaking from the clamped heparin line.The patient was transfused with two units of packed red blood cells.
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Manufacturer Narrative
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Sl-2000m2095 lot# 50355074 was returned for evaluation.The clamp was able to occlude the tubing without issue.The closed clamp on the tubing line was pressurized, no pressure leak was identified.Dhr review of the clamp lots 50210036 and 50210010 confirmed that there were no defects found during the manufacturing of this lot.No product problem or malfunction was identified.(b)(4).Considers this report closed.No additional information will be provided.
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Search Alerts/Recalls
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