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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-2131-25
Device Problem Failure to Infuse (2340)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2020
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical administration set was implicated in this issue.The customer was running a cadd-solis pump with a communication module 2131.The customer reported that the pump showed error "communication module intermittent connection".According to the pump log, the error occurred in separated occasions for 7 days.The even-log also showed the error message during a patient infusion.There were no reported adverse events for this event.
 
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Brand Name
CADD
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10748359
MDR Text Key213451458
Report Number3012307300-2020-10694
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517171969
UDI-Public15019517171969
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K170982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number21-2131-25
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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