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 Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).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.Problem: delivery accuracy out of tolerance 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 2024-02-28 were analyzed.A space line was selected and a rate of 330ml/h and a volume of 350ml was selected.The infusion started and 1 hour and 4 minutes later the volume was reached and the kvo (keep vein open) mode started.At this time, 350ml was infused.1 minute later the infusion was stopped and the line was extracted.No other abnormalities were found.3.Judgment: 3.1 the complaint could not be confirmed.

Event Description

According to the customer: when did the failure occur: during therapy reason of complaint: underinfusion via ported catheter initial pre-med and paclitaxel therapy on the same pump completed without issues.Paclitaxel is on semi-rigid bottle.300milliliters (ml) of carboplatin infusion (in soft bag) intended to finish in 1 hour was found to still physically contain half bag.Rate entered was 330ml/h and vtbi (volume to be infused) of 350ml with intention to maximize medication given to patient.Carboplatin therapy was discontinue on this pump and resumed on another pump till completion , no issues encountered on the other pump used.Patient condition stable, no medical intervention required.

• 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: 18988309
• MDR Text Key: 338730350
• Report Number: 9610825-2024-00216
• 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
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8713050
• Device Lot Number: 96969011H7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2017
• 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