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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION ALARIS EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 20028E
Device Problems Fluid/Blood Leak (1250); Separation Failure (2547)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Age: adult. The affected product has been received and the investigation is pending. A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
It was reported that leaking occurred in the medical oncology with the 0. 2 filter used separately from the tubing. They were not bonded together. Etoposide o. 4mg/ml leaked during a continuous infusion with a total dose of 100mg. The treatment was delayed and prolonged due to rectifying leaking filter. The patient and employee were exposed to the chemotherapy agent. The filter was changed during infusion and the patient discharged.
 
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Brand NameALARIS EXTENSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9687765
MDR Text Key191556383
Report Number9616066-2020-00399
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203012393
UDI-Public7613203012393
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20028E
Device Catalogue Number20028E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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