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); Irritability (2421)

Event Date 10/21/2023

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(6).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

Per medwatch mw5147971, mw5147972 and mw5147973: event 1: 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.Set: 490102, lot 0061891573.Email from customer on 07dec2023: good morning, i am writing in follow-up to your questions below.Unfortunately, we are unable to track the specific pumps as they were rotated through the hospital since this instance occurred.Our nurse manager informed me that bubbles are never present.There was discussion that occurred with your company directly at which time it was indicated that the tubing diameter was too small and not produced to the appropriate specs.The medications that were involved included levophed, amiodarone, and propofol with one of our icu patients.Fortunately, the patient was able to receive their medications and was ok.Please let me know if there are any further questions as i am happy to assist with your investigation of this incident.

• 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: 18339105
• MDR Text Key: 331060750
• Report Number: 2523676-2023-00838
• 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: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 490102
• Device Lot Number: 0061891573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: No
• 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