MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSOMAT®; SET, ADMINISTRATION, INTRA

Catalog Number 490102

Device Problem Device Alarm System (1012)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Increased Respiratory Rate (2486)

Event Type  Death  

Manufacturer Narrative

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.

Event Description

As per medwatch mw5148159: "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, mw5148160.".

• Brand Name: INFUSOMAT®
• Type of Device: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18300534
• MDR Text Key: 330162297
• Report Number: 2523676-2023-00818
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964186127
• UDI-Public: (01)04046964186127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 490102
• Device Lot Number: 0061891636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Death