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  

Event Description

As reported by the user facility: brief inquiry description: air in line alarms delayed pressor and anesthesia therapy.Detailed inquiry description: the patient arrived in icu 1100.Meds ordered to infuse and started at: profolol gtt @ 1121, fentanyl gtt 1153, levophed gtt @ 1158, ns at 1200.All of the iv pumps were primed via iv pump as we have been directed by the braun rep.And seated correctly in the pumps.The propofol which was started 1st began to alarm air bubble.The line was disconnected from pt and primed as we have been directed, this had to be done repeatedly and the drip would not infuse.Then we added the fentanyl and the levophed gtts as the pt was becoming agitated and very hypotensive (blood pressure was 63/44).The other drips were primed in the same manner and soon all the pumps were alarm "air bubble" continuously.I called the nursing supervisor immediately as we could not give any of the medications and the patient was unstable.Nurse supervisor continued to help us trouble shoot, prime lines repeatedly.We ended up changing out all the lines, all the pumps and wasted a lot of the meds thru the priming.It took us about an hour to get everything infusing as ordered.In the meantime, i had to report this to the doctor so we could get versed ivp just to get the pt sedated.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number 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 between 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.

• 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: 18107653
• MDR Text Key: 328966545
• Report Number: 2523676-2023-00718
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 490102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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