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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTE; SET, ADMINISTRATION, INTRAVASCULAR,
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ST PAUL CADD MEDICATION CASSETTE; SET, ADMINISTRATION, INTRAVASCULAR, Back to Search Results
Model Number 21-7302-24
Device Problems Device Alarm System (1012); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
Event Type  malfunction  
Event Description
Information was received indicating that during use of a smiths medical cadd medication cassette the pump exhibited constant beeping, "no disposable" and "high pressure" alarms.Per reporter a new cassette was mixed and placed and alarms were resolved.No adverse patient effects were reported.Per reporter no further details were provided.
 
Manufacturer Narrative
Additional contact information: (b)(6).
 
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Brand Name
CADD MEDICATION CASSETTE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR,
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key13112807
MDR Text Key283092754
Report Number3012307300-2021-13451
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 Nurse
Type of Report Initial
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number21-7302-24
Device Catalogue Number21-7302-24
Device Lot Number4046847
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2020
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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