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

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.

• 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 Key: 10953214
• MDR Text Key: 220470328
• Report Number: 2016493-2020-57450
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10885403812002
• UDI-Public: 10885403812002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043299
• Number of Events Reported: 1
• 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 Number: 8120
• Device Catalogue Number: 8120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 10/06/2020
• Supplement Dates FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1