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

Device Problem Device Alarm System (1012)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 06/24/2023

Event Type  Injury  

Event Description

As reported per medwatch number mw5119190: the medwatch states "rn reported b braun iv pumps were constantly alarming "air bubble."therefore, the iv medication would not infuse.Rn had normal saline connected to the patient and it was set to go for 125cc/hr but would not infuse due to "air bubble." rn troubleshooted the line by opening the iv pump and manually popping the air bubbles from the line.After multiple attempts to remove the air bubbles and thoroughly checking the line for air, the iv continued to alarm and the ns would not infuse.Rn also started a brand new line with a brand new ns bag.The pump continued to alarm air in line.Rn spent about 45 minutes troubleshooting the line until the 3rd attempt of starting a brand new iv line with ns, it finally started working correctly.The patient began to get hypotensive and tachycardic.Dr.Ordered to start levophed.The levophed was primed and ready to infuse, however it frequently alarmed "air bubble." after 4 icu nurses troubleshooted the iv line, the pump consistently alarmed "air bubble" and would not infuse the levophed.The patients blood pressure dropped to 44/32 due to the levophed not infusing properly.A brand new levophed line was started and began to infuse properly.During the transition of switching iv lines into the pumps, the pump would take about 1-2 minutes for a new line to begin infusing.This is a harmful event since the pumps take too long to begin infusing medications while switching to a new line.Patient ultimately expired 3 days later.Unclear if death was attributed to this issue or other medical issues.Follow up information received: what were the details on the procedure being performed? "np - icu nurses taking care of a medically unstable patient with a low blood pressure.Air bubbles alarm continued to pause infusion of patient's continuous normal saline infusion.Icu physician ordered a vasopressor for the extremely low blood pressure.4 total nurses tried for over 45 minutes to program the pump and get it to infuse the medication." please provide a timeline of events from treatment start, when the alarms occurred, and when the patient died."np - i do not have exact times of each event, patient was critically ill and both nurses and physician were unable to leave patient's side.The patient started becoming unstable on (b)(6) 2023 around 2230.Patient died two days on (b)(6) 2023 later due to no brain activity." after the alarm was resolved did the patient's blood pressure stabilize? "np - according to the medical record, patient's bp was not stabilized until 0038" when the pump alarmed for air in line, was there visible air in the line? for both ns and levophed."np - no air in line.4 nurses checked and tried changing out the lines multiple times." were they any other medications being infused? "np - patient was also receiving ns at 125ml/hr." was there an official cause of death? "np - brain tumor/ glioma".Did the patient have any co-morbidities? "np - yes".Please note, this report is for the set where the customer facility staff saw no air in line for the levophed.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.The actual defective device is valuable tool in investigating the cause of this incident.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.

• 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: 17466271
• MDR Text Key: 320479671
• Report Number: 2523676-2023-00393
• 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: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• 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
• Patient Outcome(s): Required Intervention