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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 Problem Material Separation (1562)
Patient Problems No Patient Involvement (2645); Not Applicable (3189)
Event Type  malfunction  
Manufacturer Narrative
Although requested, product has not been received. A follow up report will be submitted with failure investigation results should the product be received for evaluation.
 
Event Description
It was reported from the pharmacy room that primary tubing sets separated at the pump segment and that it "appears to be happening with the same batch of product. " this was happening before the product was to be used on a patient, so there is no patient involvement.
 
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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 Key10007100
MDR Text Key189309317
Report Number9616066-2020-01477
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 Received04/28/2020
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
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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