MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CONSIGNED 115V DOMESTIC HOTLINE; WARMER, THERMAL, INFUSION FLUID

Catalog Number CON-HL-90

Device Problem Noise, Audible (3273)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Returned device was received in worn physical condition.During the evaluation of the device, the initial complaint was confirmed which was caused by the age and the condition that the returned device was in.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

Event Description

Information was received indicating that a smiths medical fluid warmer was running loudly.No adverse events were reported.

• Brand Name: CONSIGNED 115V DOMESTIC HOTLINE
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn ; 3833310
• MDR Report Key: 10059814
• MDR Text Key: 191081059
• Report Number: 3012307300-2020-03976
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/14/2020

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 Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 05/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/1998
• 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