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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M COMPANY RANGER STANDARD FLOW BLOOD/FLUID WARMING SET

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3M COMPANY RANGER STANDARD FLOW BLOOD/FLUID WARMING SET Back to Search Results
Lot Number E7848
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2017
Event Type  malfunction  
Event Description
The anesthesia tech was putting together supply products to make a hotline. She tried removing the red cap from the 3m ranger standard flow blood/fluid warming set to add an extension. The red cap would not come off and she tried to use hemostats to remove it. (the hemostats did not work and actually caused more damage then not. ) an additional four fluid warmer sets were opened and rendered the same exact issues (all had the corresponding lot number e7848).
 
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Brand NameRANGER STANDARD FLOW BLOOD/FLUID WARMING SET
Type of DeviceBLOOD/FLUID WARMING SET
Manufacturer (Section D)
3M COMPANY
10351 west 70th street
eden prairie MN 55344
MDR Report Key6518411
MDR Text Key73590298
Report Number6518411
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 04/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2017
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot NumberE7848
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/21/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer04/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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