MAUDE Adverse Event Report: NULL LEVEL 1 FLOW FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that a smiths medical pump is suspected to "be bad".No adverse patient effects were reported.

Manufacturer Narrative

H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device was received with some paint chippings on the enclosure, cracked water tank cover, worn line cord, plate clip and reflux plug.The device contains old style pcb (print circuit board) and drain fitting.The customer stated problem was duplicated, the pump was not functioning.Replaced electronic assembly.Installed power switch, replaced membrane switch and label, enclosure, front cover, reservoir tank cover, plate clip, line cord, and reflux plug.Installed orings for the pm.The cause of the reported problem could not be determined.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.

• Brand Name: LEVEL 1 FLOW FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section G): NULL
• MDR Report Key: 12478169
• MDR Text Key: 271636814
• Report Number: 3012307300-2021-09383
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

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: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1