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

Model Number H1200

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Mechanical Problem (1384); Overheating of Device (1437)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

H3 - other: device has not been returned to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the device was found leaking from the return tube, "over temp alarm", has a damaged board, the heater was "out of control", and will not drain.The faults occurred before use.There was no patient involvement and no patient harm/adverse event reported.Event occurred in the emergency department, during setup for use.

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18886333
• MDR Text Key: 337445923
• Report Number: 3012307300-2024-01283
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: (01)50695085829506(11)170131
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H1200
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1