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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE PUMP, INFUSION

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CAREFUSION ALARIS PUMP MODULE PUMP, INFUSION Back to Search Results
Model Number 8100
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Patient Involvement (2645)
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 that customer is replacing (39) lvp display boards.

 
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Brand NameALARIS PUMP MODULE
Type of DevicePUMP, INFUSION
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
jeanine walter
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key10474977
MDR Text Key205537186
Report Number2016493-2020-03757
Device Sequence Number1
Product Code FRN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation BIOMEDICAL ENGINEER
Remedial Action Recall
Type of Report Initial
Report Date 08/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number8100
Device Catalogue Number8100
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? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-2822-2020

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