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

Model Number 8002950

Device Problems Device Alarm System (1012); False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2019

Event Type  malfunction  

Event Description

Information was received that a smiths medical level 1 h-1200 fast flow fluid warmer went into an overtemp alarm "early".Per the reporter, the event did not cause any harm to any patient.

Manufacturer Narrative

Evaluation results: one level 1 trauma fast flow system was returned for investigation in good condition with no physical damage to the exterior.The over temp alarm was observed when the device was powered on.The customer reported product problem was therefore confirmed.The product problem was caused by a crack in the return tube which had leaked water.Further inspection revealed that there were multiple internal components that were damaged. the crack was attributed to a design issue with the device.The main pcb and membrane switch were replaced in order to resolve the product problem.A temp-check test fixture was subsequently used on the device.The measured temperature on the device was 41.7 degrees which was within tolerance.The investigator confirmed that the device passed all functional and electrical tests.

• Brand Name: LEVEL 1 H-1200 FAST FLOW FLUID WARMER
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9460641
• MDR Text Key: 176553175
• Report Number: 3012307300-2019-06661
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: 50695085829506
• Combination Product (y/n): N
• PMA/PMN Number: BK020043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• 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: 01/21/2020
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1