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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CADD; SET, ADMINISTRATION, INTRAVASCULAR
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CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7310-24
Medical Device Problem Code Device Alarm System (1012)
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Additional contact: (b)(6).
 
Event or Problem Description
Information was received indicating that while in use of a smiths medical cadd cassette reservoir, a no disposable alarm was noted.It was also reported that the patient was missing chemotherapy, antibiotic and pain management.No further adverse effects were reported.
 
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Brand Name
CADD
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12344815
Report Number3012307300-2021-08623
Device Sequence Number3736414
Product Code FPA
UDI-Device Identifier10610586032394
UDI-Public10610586032394
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
K081156
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/19/2021
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
Operator of Device Other
Device Model Number21-7310-24
Device Catalogue Number21-7310-24
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/20/2021
Initial Report FDA Received Date08/19/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
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