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

Device Problems Device Alarm System (1012); Air/Gas in Device (4062)

Patient Problems Cardiac Arrest (1762); Tachycardia (2095)

Event Date 12/14/2023

Event Type  Death  

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.

Event Description

As reported by the user facility: brief inquiry description code blue incident with patient in icu, challenges with trouble- shooting air-in-line / occlusions while administering critical meds.Detailed inquiry description.Unfortunately, the tubing was discarded by the nursing aides following the resolution of the code blue situation.I searched through the biohazard bin (safely) but they had been discarded.I am including a detailed description of the code blue event.The code blue was called at 1628.All infusion were running into the patient via pre-existing picc line.Infusions were: epinephrine: started at 0.5mcg/kg/min started 37min into the cb.Dopamine: started at 10mcg/kg/min started 13min into the cb.Staff involved are unsure of what weight they used, so i cannot extrapolate approx.Rates.Patient went into cardiac arrest (asystole) on their medicine ward.Code blue (cb) team responded.Cpr initiated and breaths per bvm.Patient was administered push iv medications including epinephrine 1mg iv.Pulse returned 08:25 into the code blue and lost again 45sec later (and cpr restarted).After cpr restarted, pt given more ivp epinephrine and pt intubation attempted.Dopamine started at 13:36 (10mcg/kg/min).Pulse present at 16:19 and pt intubated.At this point, bp 160/107 and hr 120.Spo2 was documented as 58%.Patient lost their pulse again at 29:47 and cpr restarted.Pulse palpated again at 34:41.At this point, dopamine was increased to 20mcg/kg/min and epinephrine infusion started at 0.5mcg/kg/min.This patient was administered epinephrine 0.2mg ivp and transported down to icu at 50:45.The pumps continued to alarm during the transfer, in the elevator, and into icu.Once in icu, the icu attending was required to push epi small doses to maintain the bp as the infusions were not working.Upon arrival, nursing staff immediately began mixing all new lines (norepi, epi, and dopamine).Once set up, apparently the new lines worked well without any occlusion or air-in- line alarms.Care was continued briefly until family made the decision to withdraw care.The pumps (dopamine and epinephrine infusions) worked only for a few moments at a time during the code blue.The bags were primed: spiked on a flat surface with roller clamps closed, drip chamber 2/3 full, primed through the pump, tubing flicked during priming to move air forward, and an asv valve was connected.Troubleshooting included: priming through the pump twice (disconnected from the patient), removed from the pump to flick air bubbles forward (none visualized), removed from the pump to prime manually (as pump priming didn't work), removing the asv valve eventually, and moving the line to a new pump.

• 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 REPUBLIC 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: 18409387
• MDR Text Key: 331498257
• Report Number: 2523676-2023-00861
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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: 12/19/2023
• 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; Life Threatening