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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS PCA MODULE; PUMP, INFUSION

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CAREFUSION SD ALARIS PCA MODULE; PUMP, INFUSION Back to Search Results
Model Number 8120
Device Problem Peeled/Delaminated (1454)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The customer reported problem was confirmed.The device was repaired, passed all required testing and specifications, and released back to the customer.This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they replaced keypad, left handle, rear door, and latch module.Performed calibration.A review of the device history record for sn (b)(4) was performed from date of manufacture 01/16/2008 to the present date 11/30/2020 and note that this device has been returned for service 4 times which correlates to the customer reported issue or service repairs.Also, there were no production failures indicated on the source device.
 
Event Description
The customer reported that the device keypad was delaminating.No patient involvement.
 
Event Description
The customer reported that the device keypad was delaminating.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.This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they replaced keypad, left handle, rear door, and latch module.Performed calibration.A review of the device history record for sn (b)(6) was performed from date of manufacture 01/16/2008 to the present date 11/30/2020 and note that this device has been returned for service 4 times which correlates to the customer reported issue or service repairs.Also, there were no production failures indicated on the source device.
 
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Brand Name
ALARIS PCA MODULE
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
salvador casillas
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key10953214
MDR Text Key220470328
Report Number2016493-2020-57450
Device Sequence Number1
Product Code MEA
UDI-Device Identifier10885403812002
UDI-Public10885403812002
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043299
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8120
Device Catalogue Number8120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/05/2020
Supplement Dates Manufacturer Received10/06/2020
Supplement Dates FDA Received05/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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