As per medwatch mw5148160: "patient had laparoscopic surgery with small intestine resection on (b)(6) 2023.On (b)(6) 2023 at 2355 patient became hypotensive (bp 75/50), tachycardic (hr 20's), and tachypneic (rr high-40's).Rapid response called and the patient was transferred to the icu.Utilizing the bbraun infusomat space pumps the patient was started on levophed, and then vasopressin and neosynephrine are added.The bbraun administration sets utilized (infusomat space 15 drip/ml 120 inch tubing) are the subject of a bbraun urgent medical device correction notice dated october 23, 2023 and this notification was received via us mail at the hospital on november 6, 2023.There are no unaffected tubing administration lots in commercial circulation at this time with new improved inventory due on november 30, 2023 per the bbraun device correction notice.As noted in the correction notice bbraun has identified that their outer diameter tubing may vary in size leading to increased air alarms, including false air alarms as well as the creation of microbubbles in the tubing administration sets, further leading to additional air alarms.Due to multiple air alarms generated by the bbraun infusomat space pumps in use (8 multiple bbraun infusomat space pumps running for this critically ill patient) as a result of the administration set issue this patient experienced further instability leading to the interruption of the infusion of vasopressors, levophed and neosynephrine in a hemodynamically unstable patient.The patient has subsequently passed away on (b)(6) 2023.As such we are reporting this event to the fda.Reference reports: mw5148158, mw5148159.".
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This report has been identified as b.Braun medical internal report number (b)(4).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.No sample was provided for evaluation; however, b.Braun has initiated a voluntary medical device correction 2523676-9/26/23-004-c for multiple batches of infusomat® pump sets manufactured bewveen 01 january 2022 - 17 august 2023.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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