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

Model Number HL-90

Device Problem Defective Component (2292)

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

Event Date 08/02/2022

Event Type  malfunction  

Event Description

It was reported that the light broke off.Additional info received via email on 30-sep-2022.Event date updated.No patient involved.

Manufacturer Narrative

Operator of device 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.

Manufacturer Narrative

H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device was received with broken leds (light emitting diode) and cracked enclosure under drain fitting.Worn line cord, front cover, missing swivel for the pole clamp, stained reservoir, interlock block screw broke off, faulty microswitch and cracked reservoir cover around all four corners.The customer stated problem was duplicated.Replaced pcb (printed circuit board), enclosure, drain fitting, tank cover, front cover, interlock block assay, microswitch, line cord, and pole clamp.The cause of the reported problem was user manipulation of the device (impact).A dhr (device history review) was not performed because the device is beyond a year from its manufacture date and there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service previously.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-90
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; receiving dock; minneapolis, MN 55442
• MDR Report Key: 15550963
• MDR Text Key: 306813424
• Report Number: 3012307300-2022-21817
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: 50695085820909
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

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 Model Number: HL-90
• Device Catalogue Number: HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1