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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ RANGER¿ HIGH FLOW DISPOSABLE SET; HIGH FLOW DISPOSABLE TUBING
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3M HEALTH CARE 3M¿ RANGER¿ HIGH FLOW DISPOSABLE SET; HIGH FLOW DISPOSABLE TUBING Back to Search Results
Model Number N/A
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Not Applicable (3189)
Date of Event 10/30/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No information provided by the customer.No injury reported.Product has not been returned to 3m (b)(4) as of the date of this report.
 
Event or Problem Description
It was alleged a 3m¿ ranger¿ high flow disposable set leaked within the middle of the cassette portion of the heat exchanger.No injury was reported.Type of fluid being used was not specified.
 
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Brand Name
3M¿ RANGER¿ HIGH FLOW DISPOSABLE SET
Common Device Name
HIGH FLOW DISPOSABLE TUBING
Manufacturer (Section D)
3M HEALTH CARE
2510 conway ave
st. paul MN 55144
MDR Report Key7054335
Report Number2110898-2017-00145
Device Sequence Number16388190
Product Code BSB
UDI-Device Identifier50608223243553
UDI-Public50608223243553
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K973741
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 11/22/2017
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
Operator of Device Health Professional
Device Model NumberN/A
Device Catalogue Number24355
Device Lot NumberHX7648
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/30/2017
Initial Report FDA Received Date11/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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