MAUDE Adverse Event Report: OAKDALE HOTLINE FLUID WARMER (HL-90); WARMER, THERMAL INFUSOIN FLUID

Catalog Number CON-HL-90

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

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

Event Type  malfunction  

Event Description

It was reported that the device had a faulty display.No patient injury was reported.

Manufacturer Narrative

The product was received for evaluation.Visual and functional testing were performed.The device had wear and tear damage to the enclosure, front cover, tank cover, line cord, pole clamp, float switch, and auxiliary outlet assembly.The micro switch was bent and had a corroded thermistor.Also, the printed circuit board (pcb) was out dated and had a faulty display and power switch.The reported problem was able to be duplicated.The root cause of the reported issue was found to be a faulty pcb.The technician replaced pcb.Additional parts were replaced not related to the reported issue.The technician upgraded the pcb and power switch, which was retained under a corrective action and preventative action.The technician performed preventative maintenance (pm), device passed functional and delivery tests.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Unique identifier and 510(k) are unknown.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: HOTLINE FLUID WARMER (HL-90)
• Type of Device: WARMER, THERMAL INFUSOIN 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; clincal engineering dept; minneapolis, MN 55442
• MDR Report Key: 15320514
• MDR Text Key: 305153130
• Report Number: 3012307300-2022-16742
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• 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: 11/19/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1