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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
Device Problems Device Alarm System (1012); Pressure Problem (3012)
Patient Problem Anxiety (2328)
Event Date 05/20/2021
Event Type  Injury  
Event Description
Information was received indicating that after changing a cassette used with smiths medical cadd extension set, beeping was noted due to high pressure.It was also reported that the patient disconnected the line, primed and reattached, but the beeping sound returned and this time the patient noticed blood in the iv connection.Per patient, she believes that the issue is with her iv line and not the pump.Patient also stated she may have been without medication for 1 and a half hours, she felt she was having anxiety issues at the moment and did not feel well.The patient was instructed to go to er and take her medication.No further adverse effects were reported.(medication was life sustaining, pah).
 
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Brand Name
CADD
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key12033569
MDR Text Key257212486
Report Number3012307300-2021-06329
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/21/2021
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
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/22/2021
Initial Date FDA Received06/21/2021
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 Initial
Patient Sequence Number1
Patient Age36 YR
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