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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET,ADMINISTRATION,INTRAVASCULAR

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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET,ADMINISTRATION,INTRAVASCULAR Back to Search Results
Model Number 2420-0007
Device Problems Fluid/Blood Leak (1250); Separation Failure (2547)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2019
Event Type  malfunction  
Manufacturer Narrative
The devices have been received and the evaluation is pending. A follow up report will be submitted with investigation results once the evaluation has been completed.
 
Event Description
It was reported that the tubing came apart at y-site closest to patient and saturated the bed in the medical - surgical unit. The tubing was changed to a new set. Patient care was not delayed and it did not contribute to, or result in serious adverse impact to patient.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION 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
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9379505
MDR Text Key188704499
Report Number9616066-2019-03477
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203021012
UDI-Public7613203021012
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
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 11/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/11/2022
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number19093085
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2019
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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