MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 H-1200 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION PRODUCT CODE: BSB

Model Number 8002950

Device Problems Unintended Power Up (1162); Power Problem (3010); Intermittent Loss of Power (4016)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: returned device was received in good physical condition.During the evaluation the device the customer reported condition was confirmed.Problem source was traced to design.Dhr review will not add value to this investigation as this is a known design issue addressed in said capa.This was not reported as an out of box failure.

Event Description

Information was received that a smiths medical level 1 h-1200 fast flow fluid warmer was turning on and off by itself.No adverse patient effects were reported.

• Brand Name: LEVEL 1 H-1200 FAST FLOW FLUID WARMER
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION PRODUCT CODE: BSB
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 1265 grey fox road; st. paul, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9833533
• MDR Text Key: 183479113
• Report Number: 3012307300-2020-01974
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: 50695085829506
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8002950
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• 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