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

Catalog Number 8002950

Device Problems Crack (1135); Fluid/Blood Leak (1250); Fracture (1260)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown; no information has been provided to date.H3: other; device not returned to manufacturer.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 cracked water return tube was leaking water on the circuit board and shorting it out, causing the machine to overheat the water, and the infuser to immediately shut down.They used a wire brush to remove the "crust" from the printed circuit board (pcb) and pulled the l shaped return tube connector from the damaged end and put it in the undamaged end.There was no patient involvement and no patient harm/adverse event reported.

• 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: 18983719
• MDR Text Key: 338752598
• Report Number: 3012307300-2024-01684
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 8002950
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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