MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INFUSOMAT®; PUMP, INFUSION

Model Number 8713051U

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Asystole (4442)

Event Date 03/19/2023

Event Type  Death  

Event Description

As reported by the user facility: iv pump changed rate to 10ml/hr.In kvo mode - pump alarmed but rn was in other patient room and unable to hear.When rn heard alarm went into the room and saw the levophed dose changed to 10ml/hr.- patient then went asystole at 10:38 & died on the ventilator before being able to terminally extubate.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number 400594475.Information received for this event indicated the patient was maxed out on pressors with poor response.Care plan was for terminal extubation with family present.Dosetrac data provided for the event showed prealarm "vtbi near end" was cleared prior to the event.Per death certificate, cause of death was septic shock secondary to pneumonia and metastatic cancer.The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

• Brand Name: INFUSOMAT®
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16753272
• MDR Text Key: 313433011
• Report Number: 9610825-2023-00125
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 04046964660887
• UDI-Public: (01)04046964660887
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142596
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8713051U
• Device Catalogue Number: 8713051U
• Device Lot Number: 97040632J2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death