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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL CADD MS3 INFUSION CARTRIDGE; SET, ADMINISTRATION, INTRAVASCULAR
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NULL CADD MS3 INFUSION CARTRIDGE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Device Alarm System (1012); Excess Flow or Over-Infusion (1311)
Patient Problem Insufficient Information (4580)
Event Date 11/08/2021
Event Type  malfunction  
Event Description
Information was received indicating that a pump with cadd ms3 cartridges was alarming early when filled to 3ml with treprostinil.It was reported when filled with 2ml of treprostinil the cartridges run for the expected time.
 
Event Description
Information was received indicating that a pump with cadd ms3 cartridges was alarming early when filled to 3ml with treprostinil.It was reported when filled with 2ml of treprostinil the cartridges run for the expected time.
 
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Brand Name
CADD MS3 INFUSION CARTRIDGE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key13472823
MDR Text Key285241085
Report Number3012307300-2022-02795
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/07/2022
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
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/19/2022
Initial Date FDA Received02/07/2022
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
Patient Sequence Number1
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