Model Number SL-2010M2096 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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 report will be submitted when the investigation results become available.
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Event Description
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As reported by the user facility: customer reported five (5) bloodlines experienced the issue of the venous transducer bubble leaking into the machine.Blood actually leaked into the machine.No injury reported.
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Manufacturer Narrative
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Event 2: this report has been identified as b.Braun medical internal report number (b)(4).One (1) photo depicting the batch label info was returned for evaluation.The returned photograph was visually evaluated.It was noted that the photo depicts only the batch info of the sample and was found to be quite difficult to observe the state of venous pod.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.A review of manufacturing records was performed and indicated that there were no quality issues during the manufacturing of this lot related to the reported issue.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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