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

Catalog Number 8713050

Device Problem Inaccurate Flow Rate (1249)

Patient Problems Toxicity (2333); No Information (3190)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun (b)(4) internal report (b)(4).The device has been requested to send it for investigation to bbm laboratory in (b)(4).In the moment the device is investigate in our service laboratory.If we get new information, an investigation report will create.This report is being filed for pump (b)(4), however there were four (4) other infusion pumps in use on the patient at the time the adverse event occurred.An adverse event report has been filed for each of the pumps in use at the time of the event; the other report numbers are 9610825-2019-00370, 9610825-2019-00371, 9610825-2019-00372, and 9610825-2019-00374.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): "wrong rate".Customer information: patient had to be resuscitated due to potassium intoxication.Staff assume a wrong rate due to an incorrectly programmed infusion rate or other manipulation.Customer want an investigation of the infusion pump.A day of occurence was not reported by customer.

Manufacturer Narrative

B.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun melsungen ag(manufacturer).This report has been identified as b.Braun melsungen ag internal report (b)(4).The device has been requested to send it for investigation to bbm laboratory in melsungen, germany.During the analyzes of the history log files no flow deviation could be detected.As part of the functional check the self test of the infusomat space could be successfully performed.An infusomat space line could be inserted and was recognized by the pump.After the line selection the delivery mode could be started without any reservations.After the functional test a delivery accuracy measurement according to iec 60601-2-24 was arranged.For this the delivery accuracy measurement the pressure cut-off and the pressure limitation were checked.Furthermore the pressure stability of the safety clamp concerning the percolation (free flow possibility) was checked.The device fulfills the required values according to the specifications of the technical safety check (tsc).The device was disassembled.No damages could be detected.The complaint could not be confirmed.During a flow measurement no flow deviation could be detected.The device works within our specification.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

• Brand Name: INFUSOMAT®
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-strasse 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 8907914
• MDR Text Key: 156884085
• Report Number: 9610825-2019-00373
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8713050
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/13/2019
• Event Location: Hospital
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention