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

Model Number 24355

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/18/2024

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.Based on the photo provided the tube detached from the spike component.Possible causes of tubing to spike detachment include pulling on tubing instead of holding on to the spike, excessive force on tubing when removing spike from infusion bag, or insufficient bond of tubing to spike.Spike to tubing bond failure can also be caused by over pressurization of set above 300 mmhg.A review of the batch record found no deviations that could have caused or contributed to the reported malfunction.This continues to be a low trend in spike complaints for high flow sets.3m will continue to monitor.

Event Description

It was reported when removing the blood sheath, the lower plastic tube falls off and cannot be used.A pressure bag (max 300mmhg) was used without a pump to infuse 8 units of packed red blood cells.The customer later provided there was a leak at the inlet line of 3m¿ ranger¿ blood/fluid warming high flow set.No injuries or medical interventions were reported due to the alleged malfunction.

• Brand Name: 3M¿ RANGER¿ BLOOD/FLUID WARMING HIGH FLOW SET
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC 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: 19006412
• MDR Text Key: 338980031
• Report Number: 2110898-2024-00017
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 10707387792685
• UDI-Public: 10707387792685
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K973741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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
• Device Lot Number: HX9304
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• 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