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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMIN, INTRAVASCULAR. Back to Search Results
Model Number 2420-0007
Device Problems Material Separation (1562); Separation Failure (2547)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/30/2020
Event Type  malfunction  
Manufacturer Narrative
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 in the transplant inpatient unit when the rn was priming the line when the tubing separated from itself at the point of the safety clamp. Multiple packages were opened and the same issue occurred. The customer reported that there was no patient impact, no medical intervention required or intubation necessary.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMIN, 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
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9717638
MDR Text Key190037530
Report Number9616066-2020-00530
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203021012
UDI-Public7613203021012
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number19123083
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2019
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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