MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

Catalog Number CON-HL-390

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Event Description

It was reported that the fluid pump did not engage and overheated.No patient injury was reported.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device enclosure front cover/water tank cover cracked, drain/quick conn fitting corroded, line cord worn, pump faulty not engaging, came in with a 90 plate clip but the equipment is a 390.The customer stated problem was duplicated.Removed and replaced cover/water tank and reservoir gasket due to it leaking and being cracked, block assembly due to a hl 90 block being on the device when it is a hl 390, heater due to it being faulty, pump due to being faulty by not engaging, line cord due to it being worn, pole clamp due to it being worn, drain/quick connect fitting due to being corroded, front cover due to being worn, interlock block o-rings, reflux plug o-rings.The cause of the reported problem could not be determined.A dhr (device history review) was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer reported problem were found during the review of service and repair records., corrected data: e4: correction: customer reported to fda: no information.D5: correction: operator of the device: unknown.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• 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: 14631109
• MDR Text Key: 293548650
• Report Number: 3012307300-2022-11059
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CON-HL-390
• 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: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1