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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL CADD SET, ADMINISTRATION, INTRAVASCULAR

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NULL CADD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number FPA
Device Problem Mechanical Problem (1384)
Patient Problem Missed Dose (2561)
Event Date 08/12/2020
Event Type  malfunction  
Event Description
Information was received indicating that during use, a smiths medical cadd remote dose cord could not start working. It was also reported that the dose cord was retried with another pump but did not respond to button. Subsequently, the patient received doses through the pump's own button. It was noted that some bolus might have been missed before the issue was noted. No adverse effects were reported.
 
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Brand NameCADD
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key10532064
MDR Text Key207899441
Report Number3012307300-2020-09279
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFPA
Device Catalogue Number21-2186-25
Device Lot Number111-246-2-04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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