MAUDE Adverse Event Report: INFUSOMAT®; SET, ADMINISTRATION, INTRA

Model Number 490100

Device Problem Free or Unrestricted Flow (2945)

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

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).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: event 3: end user reports, "three times it was found that the free flow protection clip was on backwards and it could not be used in the pump as the door would not close.Two of the times there was not patient involvement but the third time was on a patient that was coding.They had to get a new set that was correctly built to use in the pump." no patient involvement.

Manufacturer Narrative

Event 3: this report has been identified as b.Braun medical internal report number (b)(4).One (1) photograph depicting the sets in the correct and incorrect orientation.Also, three (3) used physical samples in open packaging were returned from facility for evaluation.A physical sample and photograph returned from customer were visually evaluated; it was confirmed that the free flow clamp was assemble incorrectly.Based on the results of the visual evaluation of the provided photograph and samples, the reported defect of incorrect assembly can be confirmed.Please note that the lot involved was removed during a recall.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INFUSOMAT®
• Type of Device: SET, ADMINISTRATION, INTRA
• MDR Report Key: 11992106
• MDR Text Key: 255983340
• Report Number: 2523676-2021-00173
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964186080
• UDI-Public: 04046964186080
• Combination Product (y/n): N
• PMA/PMN Number: K142036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 490100
• Device Catalogue Number: 490100
• Device Lot Number: 0061761278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Date Manufacturer Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1