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U.S. Department of Health and Human Services

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

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OAKDALE LEVEL 1 HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Catalog Number CON-HL-90
Device Problem Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Information received a smiths medical fluid warming|level 1 hotline low flow systems - hl-90 pump keeps shutting off during operation.No patent involvement, as event occurred during testing.
 
Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A sample was received to perform an investigation.A visual inspection of the returned warmer found wear and tear damaged enclosure, tank cover, front cover, plate clip, and line cord.Functional testing was performed by filling the tank with water, attaching the temperature check, plugging in the line cord, and turning on the power switch.The reported problem was unable to be confirmed.The device ran all day without the pump shutting down.The enclosure, tank cover, front cover, plate clip, and line cord were replaced for cosmetic reasons and preventive maintenance was performed.A device history record (dhr) review was not performed because the results of the complaint investigation did not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.
 
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Brand Name
LEVEL 1 HOTLINE FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
OAKDALE
3350 granada ave n
oakdale MN 55128
Manufacturer (Section G)
OAKDALE
3350 granada ave n
oakdale MN 55128
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key12263722
MDR Text Key264695706
Report Number3012307300-2021-07967
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001764
Number of Events Reported1
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 02/10/2023
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 Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/06/2021
Initial Date FDA Received08/02/2021
Supplement Dates Manufacturer Received01/31/2023
Supplement Dates FDA Received02/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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