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

Catalog Number HL-90

Device Problem Defective Component (2292)

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

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection revealed the pole clamp was damaged and it was an old model.The reported issue was confirmed.No action was taken due to the age and condition of the device.The root cause of the reported issue was found to be user interface and age of the device.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

Event Description

It was reported that there was the plastic around the pole clamp at the end of the screw is now gone and it will not screw to the iv pole.No patient injury was reported.

• 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; receiving dock; minneapolis, MN 55442
• MDR Report Key: 15321547
• MDR Text Key: 305361136
• Report Number: 3012307300-2022-16793
• 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: 08/30/2022

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: Other
• Device Catalogue Number: HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/1995
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1