MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Catalog Number CON-HL-90

Device Problems Device Displays Incorrect Message (2591); Temperature Problem (3022)

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

Event Type  malfunction  

Event Description

Information received a smiths medical fluid warming|level 1 hotline low flow systems - hl-90lcd display is intermittently working and temperature not correct.No patient involvement.

Manufacturer Narrative

Correction- g1 updated.Device evaluation- the device was returned for evaluation.The device was visually examined; this showed the device had sustained damage to the lcd area of the printed circuit board.The issue was determined caused by damage during use.

Manufacturer Narrative

D4 is unknown.No product information has been provided to date.Additional information: d5, d4 catalog number this mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.A product sample was received for evaluation.Visual and functional testing were performed.Wear and tear damaged enclosure and front cover.Stripped interlock block,worn and faded line cord and pole clamp.Outdated printed circuit board (pcb) and power switch.Removed front cover and started with a visual inspection.Then filled tank with water, attached temp check, plugged in line cord, and turned on the power switch.The reported problem was confirmed.The reported issue was found to be caused by malfunctioned and damaged liquid crystal display (lcd).The root cause of the reported issue was caused by user interface.The technician replaced pcb.No causes or potential causes of the customer's reported problem were found during the review of service and repair records., corrected data: corrected d1 d2 d3 d10 g1 g5 h3 and h6.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 12328829
• MDR Text Key: 266836988
• Report Number: 3012307300-2021-08490
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001764
• 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,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1