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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS PC UNIT; PUMP, INFUSION
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CAREFUSION SD ALARIS PC UNIT; PUMP, INFUSION Back to Search Results
Model Number 8015
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The affected device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.
 
Event Description
The customer reported that the device had a keypad issue.There was no patient involvement.
 
Manufacturer Narrative
The customer reported problem was confirmed.The device was repaired, passed all required testing and specifications, and released back to the customer.A review of the device history record for sn (b)(6) was performed from date of manufacture 06/11/2019 to present date 12/08/2020 and note that this device has been returned for service once which correlates to the customer reported issue or service repairs.This shall be reviewed as part of part usage trending in complaint review board.Also, there were no production failures indicated on the source device.
 
Event Description
The customer reported that the device had a keypad issue.There was no patient involvement.
 
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Brand Name
ALARIS PC UNIT
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key10767550
MDR Text Key214108466
Report Number2016493-2020-30774
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10885403801518
UDI-Public10885403801518
Combination Product (y/n)N
PMA/PMN Number
K091308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8015
Device Catalogue Number8015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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