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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M HEALTH CARE 3M RANGER(TM) HIGH FLOW BLOOD/FLUID DISPOSABLE SET HIGH FLOW DISPOSABLE TUBING

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3M HEALTH CARE 3M RANGER(TM) HIGH FLOW BLOOD/FLUID DISPOSABLE SET HIGH FLOW DISPOSABLE TUBING Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Not Applicable (3189)
Event Date 03/10/2017
Event Type  malfunction  
Manufacturer Narrative
No patient information was provided and no reported injury. 3m implemented a new dehp free material to enhance the material properties on all 3m ranger(tm) fluid warming disposable products in 2013. Subsequent to this change 3m received a higher trend of complaints applicable to leaks within selected areas of the disposable tubing connections. 3m implemented a solvent improvement process change in late 2015 to address this type of event. This improvement was to the solvent bond process to reduced leaks on all of the following areas; y-connector, drip chamber, bubble trap and tube fitting of the high flow disposable set. The change was implemented to increase strength and to minimize leaks. 3m continues to monitor their complaints to confirm the effectiveness of the change made. The lot number of the product was provided and was produced before the solvent improvement change. 3m continues to monitor these types of complaints.
 
Event Description
It was alleged that a 3m ranger(tm) high flow blood/fluid disposable set leaked during at the y connection. The type of fluid was not indicated and there was no reported patient injury.
 
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Brand Name3M RANGER(TM) HIGH FLOW BLOOD/FLUID DISPOSABLE SET
Type of DeviceHIGH 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
linda johnsen
3m center, building 275-5w-06
2510 conway ave
st. paul, MN 55144
6517374376
MDR Report Key6556041
MDR Text Key74791108
Report Number2110898-2017-00071
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K973741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2017
Device Model NumberN/A
Device Catalogue Number24355
Device Lot NumberHX7485
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/28/2014
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: 05/09/2017 Patient Sequence Number: 1
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