MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSOMAT SPACE PUMP IV SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 490102

Patient Problems Low Blood Pressure/ Hypotension (1914); Irritability (2421)

Event Date 10/21/2023

Event Type  malfunction  

Event Description

Braun iv pumps kept alarming air bubble in line when attempting to deliver iv medications to patient.Patient had three lines for three separate medication on 3 separate pumps all with the same issue.Pumps were set up and primed correctly as directed by braun.The medications were delayed by hour; patient was agitated and hypotensive.Had to change out tubing several times to finally get medication to patient which also resulted in the wasting of medications to prime the lines.Company was informed and indicated they were aware of the issue.Company indicated they were aware that it is the size of the tubing being used in the pumps.An inaccurate diameter was manufactured which causes the pumps to indicate an error of an air bubble when there are no bubbles in the line.Reference reports: mw5147971, mw5147973.

• Brand Name: INFUSOMAT SPACE PUMP IV SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 18101325
• MDR Text Key: 328112504
• Report Number: MW5147972
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 490102
• Device Lot Number: 0061891573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFUSOMAT SPACE PUMP
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White