MAUDE Adverse Event Report: ST PAUL HOTLINE 3 BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Catalog Number HL-390

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Manufacturer Narrative

A product sample was received for evaluation.Visual inspection and functional testing were performed.The enclosure, front cover, line cord and pole clamp were damaged.During functional testing, the technician was able to duplicate the reported issue of failed ground bond/ electrical test.The technician found out that one of the ground wires was loose and the nut securing the loose ground wire was tightened to resolve the reported issue.All the damaged parts were replaced.The technician performed the preventive maintenance (pm).The device passed all the functional testing.The root cause of failed ground bond/ electrical test was determined to be the loose ground wire.Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.(udi number) is unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the device failed the ground bond/ electrical test.No patient injury was reported.

• Brand Name: HOTLINE 3 BLOOD AND FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15276903
• MDR Text Key: 304987121
• Report Number: 3012307300-2022-15853
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• 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: 08/23/2022

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 Catalogue Number: HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2022
• Initial Date FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1