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

Model Number 8713050

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.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 information by bbm sales organization in singapore: "underinfusion" according to the customer: reason of complaint: under infusion of oxaliplatin oxaliplatin therapy was initiated around 1600 hours with rate 151 milliliters and hour, volume to be infused entered approximately 300 milliliters, estimated to complete around 2 hours.Concurrently follinic acid was also administered at a rate of 170 milliliters and hour, also expected to completed in 2 hours time.Both therapies expected to complete together.When follinic acid therapy was completed 2 hours later, oxaliplatin therapy bag was observed to be still 1/3 remaining.No flattening of the pump segment was observed.Patient condition stable, no medical intervention required.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample / underinfusion.The device was not available.Only the history data was sent for investigation.2.Results: 2.1 the device history files from (b)(6) 2024 were analyzed.A space line was selected and the infusion started with rate of 151ml/h and a volume of 350ml (based on the error description, it was 300ml) at 04:02pm.The infusion was interrupted by the customer for 4 minutes at 05:35pm.The infusion was continued at 05:39pm.The infusion was stopped by the customer at 06:07pm.At this time, 306,95ml was infused.The line was extracted.No other abnormalities were found.3.Judgment: 3.1 the complaint could not be confirmed.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 str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18711396
• MDR Text Key: 335471953
• Report Number: 9610825-2024-00082
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8713050
• Device Lot Number: 96967112C7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• 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