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

Model Number 490100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/16/2023

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.Please note that this report is for the pump set in which there is no indication of a malfunction at this time.

Event Description

As reported by the user facility: description of the patient event could not infuse critical drip of norepi the clinician kept receiving downstream occlusion alarms that they could not resolve.Patient injury or death yes - death.These are the additional details b.Braun obtained with the account after a meeting on 22.June.2023: infusion started on (b)(6).No occlusion alarms, until 1:22 a.M.Of (b)(6); pressure alarm at 3:09 a.M., then 4:56 a.M.The infusion was infusing through a triple lumen catheter in the neck.Other drugs were running, but not on the same lumen (they do not piggyback or double-up vasopressors).There were four (4) or five (5) other pumps connected to the patient.The drugs the patient was receiving were norepinephrine, fentanyl, dextrose, levophed, vasopressin, and bicarb.The patient was very sick and they were talking about the potential to put in place comfort measures for end of life when the incident occurred.The patient's blood pressure had not been great all day prior to the event.All lines other than the norepinephrine were running without issue except the fentanyl had to be increased once.It was reported that at one point the patient seemed to go "rigid" and had some "stiffening".That may have lead them to increase the doserate of fentanyl from 50 - 75, but it is unclear whether that was the reason for the increase in rate.There were no identified kinks or blockages in the norepinephrine line and they had good blood return.They even tried to adjust the patient in case there was some occlusion in the anatomy, but this did not have an impact on the occlusion alarms.Cather placements: patient had a triple lumen and a mid-line in the right upper arm and a peripheral iv in the left arm.Only one lumen of the triple-lumen was being used for the patient.Customer was only able to get dosetrac info for the morning of (b)(6).Likely because the wireless signal in the area may not be good.Possible lot numbers: lot 0061875889; expiry date 01/31/2026; production date 02/13/2023.Lot 0061880238; expiry date 02/28/2026; production date 03/22/2023.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Please note that originally when the report was received, it was unclear if the death mentioned was related.However, a call was held between b.Braun and the clinical nurse specialist medication safety for (b)(6) on 22.Jun.2023.During the call on 22jun2023, the clinician identified that the cause of death was believed to be sepsis but provided contact information to the risk management department for further details.Multiple attempts (2 emails on 23jun2023 & 29jun2023, one phone call on 07jul2023, and a site visit on 12jul2023) were made to discuss and obtain additional details regarding the patient outcome.At this time, no additional information has been provided by the customer.As such, this report is submitted amending section b2, h1, and h6 to reflect serious injury.Representative from b.Braun went to the hospital to retrieve the set used within the incident and sent with pump to affiliate site for testing; however, unfortunately, the actual device was inadvertently discarded during decontamination and not available for further testing at the manufacturing site.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.

Event Description

Please note that during the call on 22.Jun.2023 between b.Braun and the clinical nurse specialist medication safety for (b)(6) the clinician identified that the cause of death was believed to be sepsis.

• 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: 17299519
• MDR Text Key: 318787917
• Report Number: 2523676-2023-00323
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964186080
• UDI-Public: (01)04046964186080
• 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
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 490100
• Device Catalogue Number: 490100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 06/20/2023
• Supplement Dates FDA Received: 09/18/2023
• 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): Death; Required Intervention