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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

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SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number HL-90
Device Problems Device Alarm System (1012); Fracture (1260); Insufficient Heating (1287)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2024
Event Type  malfunction  
Manufacturer Narrative
B3: date of event and d5.Operator of device 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 has a crack in the main body.Error alarm sound doesn't stop.Water doesn't warm.There was no patient involvement and no patient harm/adverse event reported.
 
Manufacturer Narrative
One warmer device was received for investigation.During visual inspection, cracks were observed on the cover of the circulating water tank.The reported issue was confirmed during functional testing when the device temperature display was inaccurate and then overt temperature alarm was activated.The investigation traced the issue to the device circuit board, which was determined to be damaged.The investigation attributed the root cause of this condition to a physical impact.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.Per the customer's request, no repairs were performed on the device, and it was returned to the customer.
 
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Brand Name
LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key18658369
MDR Text Key334799241
Report Number3012307300-2024-00603
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K911383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/21/2024
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 Other
Device Model NumberHL-90
Device Catalogue NumberHL-90JP
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/15/2024
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/11/2024
Initial Date FDA Received02/07/2024
Supplement Dates Manufacturer Received01/11/2024
Supplement Dates FDA Received03/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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