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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M HEALTH CARE 3M RANGER BLOOD/FLUID WARMING SYSTEM STANDARD FLOW STANDARD FLOW DISPOSABLE TUBING

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3M HEALTH CARE 3M RANGER BLOOD/FLUID WARMING SYSTEM STANDARD FLOW STANDARD FLOW DISPOSABLE TUBING Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Air Embolism (1697)
Event Type  Injury  
Manufacturer Narrative
Date of event is unknown. Expiration date and lot number is unknown. Unknown if device was serviced by a third party. Unknown if device is available for evaluation. Reporters telephone number, email and address are unknown. Unknown if reporter is a healthcare professional. Manufacture date is unknown. 3m¿ ranger¿ standard flow disposable set, model 24200 is not a pediatric set, age of patient is unknown. Unable to confirm if the ifu were followed. Type of injury and outcome is unknown. Product is not available to be returned; therefore, not returned to 3m for analysis. 3m¿ is unable to verify the malfunction, identify exact location and root cause without the sample. 3m¿ will continue to investigate and monitor.
 
Event Description
A hospital in (b)(6) alleged a pediatric patient experienced an air embolism with use of 3m¿ ranger¿ high flow disposable set, model 24200. Customer reported this was due to air in the tubing following priming and heat exchanger collapsing. Injury was reported.
 
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Brand Name3M RANGER BLOOD/FLUID WARMING SYSTEM STANDARD FLOW
Type of DeviceSTANDARD FLOW DISPOSABLE TUBING
Manufacturer (Section D)
3M HEALTH CARE
2510 conway ave
st. paul MN 55144
Manufacturer (Section G)
NYPRO PRECISION ASSEMBLIES
sor juana ines de la cruz
cd. industrial
tijuana, tijuana baja california 22444
MX 22444
Manufacturer Contact
dianne gibbs
3m center, building 275-5w-06
2510 conway ave
st. paul, MN 55144
6517379117
MDR Report Key11837582
MDR Text Key251471389
Report Number2110898-2021-00032
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
K973741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 05/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number24200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/17/2021 Patient Sequence Number: 1
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