Event 1: this report has been identified as b.Braun medical internal report number (b)(4).All information associated with this event was submitted to the bloodline manufacturer for further evaluation.Based on the evaluation results, three photographs of the tubing were provided and the tubing set was returned for product evaluation.Visual inspection of the photographs and returned sample confirmed the reported issue as the arterial line was broken where the pump segment connects to the pod.Although the reported defect was confirmed, the manufacturer was unable to determine a root cause of the reported defect.A search of the complaint database for this blood tubing set lot number shows no additional complaints of damaged components as of complaint closure, indicating this is an infrequent occurrence.Additionally, a review of manufacturing records for sl-2000m2095d lot 11155029 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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