MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. BRAUN INFUSOMAT SPACE 15 DRIP/ML 120 INCH TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 490102

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

Event Date 11/08/2023

Event Type  Death  

Event Description

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.

• Brand Name: BRAUN INFUSOMAT SPACE 15 DRIP/ML 120 INCH TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 18147705
• MDR Text Key: 328297867
• Report Number: MW5148160
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 490102
• Device Catalogue Number: 490102
• Device Lot Number: 00618968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BBRAUN INFUSOMAT SPACE PUMPS; LEVOPHED; NEO-SYNEPHRINE
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White