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

Model Number	8120
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device will be returned per customer.The customer complaint could not be confirmed because the device was not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the device received an alarm - error code message.The error code displayed was 351.6760.There was no patient involvement.
Additional Manufacturer Narrative
A review of the complaint history record was performed for the (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.A review of the device history record showed the device had a manufacture date of 12jul2017.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 (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.
Event or Problem Description
It was reported that the device received an alarm - error code message.The error code displayed was 351.6760.There was no patient involvement.

• Brand Name: ALARIS PCA
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11590926
• Report Number: 2016493-2021-501394
• Device Sequence Number: 4183081
• Product Code: FRN
• UDI-Device Identifier: 10885403494291
• UDI-Public: 10885403494291
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: 8120
• Device Catalogue Number: 8120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1