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U.S. Department of Health and Human Services

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

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OAKDALE LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-390
Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Date of event and udi number 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 was leaking form the reservoir.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
 
Manufacturer Narrative
Other text: d10.Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.G1,2 email is: regulatory.Responses@icumed.Com.One device was received.Per visual inspection, the water tank cover was cracked, and drain/quick connector was corroded.Per functional testing, the reservoir was leaking from both side and the bottom of the water tank cover.The complaint was confirmed.The root cause was a worn gasket.It was unknown what caused the condition.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Replaced the reservoir gasket, water tank cover drain/quick connector fitting.Replaced line cord due to it failed electrical test.Perform preventative maintenance (pm) and calibrated.The device passed all functional and delivery tests.
 
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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
Manufacturer Contact
jim vegel
MDR Report Key16640469
MDR Text Key312340853
Report Number3012307300-2023-03248
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier10695085002796
UDI-Public10695085002796
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K911383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/27/2023
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 Model NumberHL-390
Device Catalogue NumberCON-HL-390
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/09/2023
Initial Date FDA Received03/29/2023
Supplement Dates Manufacturer Received11/28/2023
Supplement Dates FDA Received12/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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