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

Model Number 8120

Device Problems Device Alarm System (1012); Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The affected device has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Device received with pending investigation.

Event Description

It was reported by the customer that the device received a channel error.There was no patient involvement.

Manufacturer Narrative

This device was evaluated and repaired through the service repair process.Based on the findings, the probable root cause of the reported issue was, due to electrical failure of the keypad, unresponsive key.A review of the device history record showed, the device had a manufacture date of 28aug2019.The review was performed, from the date of manufacture to the date of product release for distribution.A review of the device history record for sn#: (b)(6) was performed.Which confirmed, that this device was not involved in a production failure.Which correlates to the customer reported issue.A review of the complaint history record was performed, for the sn#: (b)(6).Which did not confirm, similar complaints with the same or related failure mode for this customer.

Event Description

It was reported by the customer, that the device received a channel error.There was no patient involvement.

Manufacturer Narrative

Additional information added to: d8 this device was evaluated and repaired through the service repair process.Based on the findings, the probable root cause of the reported issue was due to electrical failure of the keypad - unresponsive key.A review of the device history record showed the device had a manufacture date of 28aug2019.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record was performed for the sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.

Event Description

It was reported by the customer that the device received a channel error.There was no patient involvement.

• 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: shari lynn groth ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11619028
• MDR Text Key: 243927758
• Report Number: 2016493-2021-502099
• 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: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2021

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: 03/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 05/25/2021; 03/18/2021
• Supplement Dates FDA Received: 06/04/2021; 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2909-2020
• Patient Sequence Number: 1