MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown; no information has been provided to date.E1 - initial reporter phone: (b)(6).One device was received in good condition.Per visual inspection, the tank cover had visible cracks around screws.The complaint was confirmed.The most probable cause was the screws may have been tightened too much.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The tank cover and gasket were replaced.Device works normally.The temperature was stable and in the range.

Event Description

It was reported that the tank was leaking.There was unknown patient involvement and unknown patient harm/adverse event reported.

• Brand Name: CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• 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: 19014906
• MDR Text Key: 339055338
• Report Number: 3012307300-2024-01936
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: 50695085820909
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K911383
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: HL-90-INT-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Date Manufacturer Received: 03/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2019
• 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