MAUDE Adverse Event Report: NULL LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-90; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problem Defective Device (2588)

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

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

Udi is unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the device with significant technical wear and tear.No patient involvement reported.

Manufacturer Narrative

H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.The customer reported problem was not related to any previous repair.Visual inspection found the device in good condition; some small tears and wear were found on the enclosure.There was no evidence of the error in the event history log.The customer reported problem was not verified/duplicated.The investigation was unable to determine or confirm the cause of the complaint.No fault was found.The root cause was unknown.The product is beyond a year from manufacture date and there was no indication or evidence provided in the complaint of a manufacturing defect, so a device history record review was not performed.The service history review identified there was no indication or evidence provided in the complaint or service history of a service issue.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-90
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section G): NULL
• MDR Report Key: 15754049
• MDR Text Key: 307185312
• Report Number: 3012307300-2022-26892
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: HL-90-INT-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1