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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CADD CASSETTE RESERVOIRS SET, ADMINISTRATION, INTRAVASCULAR

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CADD CASSETTE RESERVOIRS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Fluid Leak (1250); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Information was received indicating that this smiths medical cadd cassette reservoirs inner bag ruptured. Medication: veletri. No patient injury reported.
 
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Brand NameCADD CASSETTE RESERVOIRS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12627766
MDR Text Key276353387
Report Number3012307300-2021-09941
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial
Report Date 10/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/15/2021
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 Unkown

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