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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 Fluid Leak (1250)
Patient Problem Not Applicable (3189)
Event Date 04/05/2019
Event Type  malfunction  
Manufacturer Narrative
The product sample was discarded by the customer; therefore, analysis of the product could not be conducted. Without a sample or product photo, root cause of reported issue and exact location of the reported leak was unable to be determined. Based on the information provided, issue appears to be a heat exchanger leak. There currently have been no change in complaint levels for hex leaks. 3m will continue to monitor. End of report.
 
Event Description
A hospital anesthesia technician reported a (b)(6) male patient, weighing 20kg, had liver transplant surgery on (b)(6) 2019. The patient was being administered rbc fluid through a 3m¿ ranger¿ standard flow disposable set (model 24200) warmed by a 3m¿ ranger¿ warming unit (model not specified). Prior to administration, the fluid warming cassette was loaded into the warming unit. The warming unit was turned off at this time. The patient was administered rbc fluid for approximately 2 to 2 ½ hours. No pressure device or pump was used. No manual pressure was applied to the fluid bags. The employee alleged, approximately 2 to 2 ½ hours after the start of administration, the anesthesiologist discovered blood was leaking from the ranger ¿ unit. The anesthesiologist took action to prevent any bodily harm to the patient. The employee reported the warming unit was unable to be evaluated at the hospital due to blood contamination.
 
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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 Key8564910
MDR Text Key144105072
Report Number2110898-2019-00059
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K973741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/18/2021
Device Model NumberN/A
Device Catalogue Number24200
Device Lot NumberB8247
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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