MAUDE Adverse Event Report: 3M COMPANY 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET; WARMER, BLOOD, NONELECTROMAGNETIC RADIATION

Model Number 24355

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned; therefore, 3m is unable to verify the leak, identify exact location and root cause at this time.Possible causes of the cassette leaking include over-pressurization above 300mmhg, insertion or removal of pressurized heat exchanger from heating unit, and heat exchanger not fully inserted into the heating unit.3m will continue to monitor.

Event Description

It was reported there have been multiple leaks at the cassette of 3m¿ ranger¿ blood/fluid warming high flow set.Some occasions were found to be when blood products are being transferred.No injuries or medical interventions were required due to the alleged malfunction.

• Brand Name: 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET
• Type of Device: WARMER, BLOOD, NONELECTROMAGNETIC RADIATION
• Manufacturer (Section D): 3M COMPANY; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): NPA DE MEXICO S. DE R.L. DE C.V.; sor juana ines de la cruz #201; 50 interior 5, cd. industrial; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6514612670
• MDR Report Key: 18817168
• MDR Text Key: 336736275
• Report Number: 2110898-2024-00010
• Device Sequence Number: 1
• Product Code: BSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24355
• Device Catalogue Number: 24355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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