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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET,ADMININSTRATION,INTRAVASCULAR Back to Search Results
Model Number 2420-0007
Device Problem Material Separation (1562)
Patient Problem Not Applicable (3189)
Event Date 04/10/2020
Event Type  malfunction  
Manufacturer Narrative
Although requested, device has not been received. A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
It was reported from the iv pharmacy room of the infusion clinic that a primary tubing set separated at the pump segment. Another set was used instead. There was no patient involvement.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceSET,ADMININSTRATION,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 Key10012526
MDR Text Key189453546
Report Number9616066-2020-01484
Device Sequence Number1
Product Code FPA
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 Pharmacist
Type of Report Initial,Followup
Report Date 04/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2020
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 Number20033007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2020
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 Manufactured03/04/2020
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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