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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE RESERVOIRS; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD CASSETTE RESERVOIRS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7302-24
Device Problems Device Alarm System (1012); Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/29/2021
Event Type  malfunction  
Event Description
Information was received indicating that during use of this smiths medical cadd cassette reservoirs, the pump exhibited "no disposable" alarm.No patient injury reported.
 
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Brand Name
CADD CASSETTE RESERVOIRS
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 Key11899249
MDR Text Key253112806
Report Number3012307300-2021-05229
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027239
UDI-Public10610586027239
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-7302-24
Device Catalogue Number21-7302-24
Device Lot Number4093649
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/30/2021
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 Unknown
Patient Sequence Number1
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