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

Catalog Number 363430

Device Problem Device Alarm System (1012)

Patient Problems Low Blood Pressure/ Hypotension (1914); Renal Failure (2041); Sepsis (2067)

Event Date 09/08/2023

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number: (b)(4): a delay in medication administration occurred due to alarms for air in line.Per the customer, the patient was decompensating due to complications of sepsis and the alarms temporarily delayed the infusion of emergent medications.Per internal investigations, bbmi is aware that iv set properties can impact air sensor values being detected by the iv pump.Although the patient expired, the temporary delay in medication infusions that occurred near 24 hours prior to expiration was unrelated to the cause of death.As such, a medical device report will be filed against the pump for adverse event without product problem (reference mdr: 9610825-2023-00451), and the death box in sections b2 and h1 are not checked within this report.The devices involved are not available and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: icu patient was on multiple medications, levophed, neosyneprine, bicarb and vasopressen.All pumps had repeated air in line alarms.Pumps were swapped and tubing was changed and still had alarms causing patient to not get needed meds.The doctors and nursing staff were scrambling to get these drips going.The patients conditioned worsened but he is now on comfort care.They didn't immediately say the pumps were the cause, but surely the interruption of med administration didn't help the situation.On (b)(6) 2023, the customer further indicated device samples, serial numbers, or batch numbers were not available.They further clarified that the patient involved decompensated on (b)(6) 2023 and passed the same day.Additional information was received 01oct2023 from the customer: 1.What was the official cause of death? severe metabolic acidosis, secondary to renal failure, secondary to shock.2.Is an incident report available for the patient involved? internal voluntary reporting at cmh; same report sent to bbraun on same day.3.What were the factors that influenced the decision to place the patient into comfort care? labs worsening; pt dnr/dni.How much time had passed between the delays experienced and the decision to transfer the patient to comfort care? less than 24 hrs.4.Was the patient already being transferred to comfort care when the air in line delay occurred, or were they moved to comfort care as a result of the infusion delay? patient was decompensating and hypotensive requiring transfer from telemetry unit to icu.This was when all ordered pressors had alarms.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for further evaluation.An approved project is in place to further address issues with air in line.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 18109
• Manufacturer (Section G): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las america; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17890553
• MDR Text Key: 325235509
• Report Number: 2523676-2023-00601
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964294679
• UDI-Public: (01)04046964294679
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 363430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention