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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 Problem Fail-Safe Problem (2936)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2019
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
The reported feedback suggests frequent ail alarm lead to medication waste. From the reported information there are no indications of serious injury to the patient or user as a result of this incident.
 
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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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9178972
MDR Text Key162875895
Report Number9616066-2019-02836
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSA
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 09/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
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
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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