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U.S. Department of Health and Human Services

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

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OAKDALE LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-90; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the device is leaking.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
 
Manufacturer Narrative
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, other text: h6: event problem and evaluation codes: updated.H10: manufacturing device history record 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's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found cracked enclosure and tank cover, faded line cord, outdated printed circuit board (pcb) and power switch.Functional testing found the device leaked from a crack near the drain tube confirming the customer complaint.The root cause of the reported issue was found to be wear and tear damage from repeated use of the drain tube.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4)., corrected data: d4: model num.
 
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Brand Name
LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-90
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
677 church st
minneapolis, MN 55442
MDR Report Key15914492
MDR Text Key307814447
Report Number3012307300-2022-27737
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/27/2023
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-90
Device Catalogue NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/22/2022
Initial Date FDA Received12/05/2022
Supplement Dates Manufacturer Received01/13/2023
Supplement Dates FDA Received04/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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