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Model Number SL-2010M2096 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Type
malfunction
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Event Description
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As reported by the user facility: event 6: "hospital clinical coordinator has noted that there are major kinks on the lines, one set had a small crack and ended up having air in pt's blood, unable to return blood.Some had the saline going to the venous tranducer line causing strike-through.Saline going up to transducer connector in the machine.If saline was going to the transducer connector, blood could also go there, causing what we call strike through.To my knowledge no harm was caused to the pt, and we had a minimal blood loss.".
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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
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Manufacturer Narrative
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Event 6: this report has been identified as b.Braun medical internal report number (b)(4).No sample or photo were submitted to the manufacturer for evaluation.Further investigation of the complaint is not possible.The actual defective device is a valuable tool in investigating the cause of this incident.While the complaint is not confirmed, a potential root cause could be from the manufacturing machine, due to high pressure of return can stress the product and generate a perforation in the pod membrane.An approved project is in place to further address issues of this nature.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
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Search Alerts/Recalls
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