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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 Date 12/01/2022
Event Type  malfunction  
Manufacturer Narrative
No information has been provided to date.A product sample was received and is awaiting evaluation and 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 reporting that the device was 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
Other, other text: additional event information received indicating date of event (updated b5, b3) h6: event problem and evaluation codes: update not required a product sample was received and is awaiting evaluation and 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
Additional info received on 15-dec-2022: this was reported december 1st 2022 with no further information.
 
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 a cracked tank cover.Outdated printed circuit board (pcb) and power switch.Functional testing found the device leaked water from the reservoir confirming the customer complaint.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.The root cause of the issue could not be determined.This issue will be monitored via trend analysis for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# (b)(4).
 
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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
minneapolis, MN 55442
MDR Report Key15960852
MDR Text Key308072384
Report Number3012307300-2022-27819
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,Followup
Report Date 04/24/2023
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
Date Returned to Manufacturer12/05/2022
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/22/2022
Initial Date FDA Received12/12/2022
Supplement Dates Manufacturer Received12/15/2022
12/22/2022
Supplement Dates FDA Received01/13/2023
04/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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