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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SET, ADMIN, HIGH VOL, 1.2 FLTR, FS, TOTM; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. SET, ADMIN, HIGH VOL, 1.2 FLTR, FS, TOTM; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7381-24
Device Problem False Alarm (1013)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical administration set used in conjunction with smiths medical cadd solis pumps was getting many air detector alarms with total parental nutrition (tpn) patients when there is little to no air visible.There was no adverse events reported.
 
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Brand Name
SET, ADMIN, HIGH VOL, 1.2 FLTR, FS, TOTM
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, mn 
3833310
MDR Report Key9814052
MDR Text Key182908467
Report Number3012307300-2020-01898
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027468
UDI-Public10610586027468
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number21-7381-24
Device Catalogue Number21-7381-24
Was Device Available for Evaluation? No
Date Manufacturer Received02/12/2020
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
Type of Device Usage Unknown
Patient Sequence Number1
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