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U.S. Department of Health and Human Services

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

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OAKDALE LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problems Overheating of Device (1437); Failure to Pump (1502); Device Difficult to Maintain (3134)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the device failed preventive maintenance.Device was not pumping the water through, causing it to go into over temperature.No adverse effects have been reported.
 
Manufacturer Narrative
Other text: b3: date of event 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.
 
Manufacturer Narrative
Other text: d10.Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1, 2 email is: regulatory.Responses@icumed.Com.One device was received.Per visual inspection, cracked tank cover, noisy pump, stained reservoir, cracked and leaking enclosure, bent micro switch, and corroded drain fitting.Outdated printed circuit board (pcb) and power switch.Per functional testing, the pump was intermittent, and the temperature was unstable confirming both issues.The root cause for the pump not working properly and consistently was caused by the bent micro switch which triggers the pump.Not holding the temperature was caused by the pot on the pcb (used for temperature settings) being damaged.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.No action taken due to the condition of the device.It was deemed beyond economical repair and was scrapped.
 
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Brand Name
LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
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 Key18160347
MDR Text Key328409536
Report Number3012307300-2023-10579
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier50695085820909
UDI-Public50695085820909
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 01/04/2024
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-90
Device Catalogue NumberHL-90
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 10/31/2023
Initial Date FDA Received11/17/2023
Supplement Dates Manufacturer Received12/05/2023
Supplement Dates FDA Received01/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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