MAUDE Adverse Event Report: 3M COMPANY RANGER SET BLOOD WARMING; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number 24200

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 06/04/2021

Event Type  malfunction  

Event Description

3m ranger cassette that ruptured - not yet under pressure.Fda safety report id# (b)(4).

• Brand Name: RANGER SET BLOOD WARMING
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 11982941
• MDR Text Key: 256039396
• Report Number: MW5101831
• Device Sequence Number: 1
• Product Code: BSB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24200
• Device Lot Number: B8798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1