MAUDE Adverse Event Report: ST PAUL LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number HL-390

Device Problems Crack (1135); Failure to Power Up (1476); Power Problem (3010)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

One level 1 hotline blood and fluid warmer was returned for analysis.The enclosure was observed to be cracked, heavy stains were found to the enclosure, crack to both covers, and the line cord was worn upon visual inspection.The tank was filled with water, the temp check was attached, the line cord was plugged in and the unit was turned on; confirming complaint of no power.Based on the evidence the root cause was found to be due to a faulty pcb.

Event Description

Information was received indicating that a smiths medical level 1 hotline blood and fluid warmer did not have power.There were no reported adverse effects.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10053746
• MDR Text Key: 190845861
• Report Number: 3012307300-2020-04362
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HL-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2020
• Initial Date FDA Received: 05/13/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2014
• 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