MAUDE Adverse Event Report: OAKDALE HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Catalog Number CON-HL-90

Device Problem Failure to Calibrate (2440)

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

Event Type  malfunction  

Event Description

It was reported that the device could not be calibrated.No patient injury was reported.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Upon visual inspection, it was observed that the pump was noisy and there were cracks in the tank and front covers.Functional testing involved filling the tank with water, attaching a temp check, plugging in the line cord, and turning on the power switch.Testing was unable to confirm the customer complaint of being unable to calibrate.The root cause of the reported issue could not be found as the customer complaint could not be confirmed.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: HOTLINE BLOOD AND 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
• MDR Report Key: 15299915
• MDR Text Key: 305279944
• Report Number: 3012307300-2022-16318
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1