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

Model Number HL-90

Device Problem Leak/Splash (1354)

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

Event Date 09/13/2022

Event Type  malfunction  

Manufacturer Narrative

Udi is unknown.No information has been provided to date.A product sample was received and is awaiting evaluation and 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 unit had an internal leak.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

The event date was updated.A product sample was received and is awaiting evaluation and 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

Additional information was received via email on 8-dec-2022.The event date was updated.No patient was involved.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H10: device evaluation: the device was returned for investigation.Visual inspection and functional tests were performed.The customer reported problem was not related to a previous repair.Visual inspection found the device with foreign material in the reservoir tank, cracked enclosure underneath the drain fitting, and the enclosure contained minor wear and tear.There was no evidence of the reported error in the event history log (ehl).The reported problem was duplicated/verified during functional testing.The crack was large enough to leak water, confirming the customer complaint.The most probable root cause was due to wear and tear over time from the elbow fitting installation.The investigation was unable to determine who or what caused it.No action was taken due to the age and condition of the device.It was deemed beyond economical repair and will be scrapped.The root cause was unknown.The product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history record review was not performed.Service history review identified this device has not been in for service previously.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-90
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15870979
• MDR Text Key: 307669715
• Report Number: 3012307300-2022-27496
• 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,Followup,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• 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: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1