MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; SERVER, INFUSION

Model Number	8975
Medical Device Problem Codes	Computer System Security Problem (2899); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.Device was not returned to manufacturing facility.
Event or Problem Description
It was reported that product security issues were found during a penetration test on alaris systems manager performed by the customer.The test was performed prior to go-live and there was no patient involvement.
Event or Problem Description
It was reported that product security issues were found during a penetration test on alaris systems manager performed by the customer.The test was performed prior to go-live and there was no patient involvement.
Additional Manufacturer Narrative
Omit : c20 - no findings available, d15 - cause not established.

• Brand Name: ALARIS SYSTEM
• Common Device Name: SERVER, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 16319998
• Report Number: 2016493-2023-108277
• Device Sequence Number: 7993346
• Product Code: FRN
• UDI-Device Identifier: 10885403897504
• UDI-Public: (01)10885403897504
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K133532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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: 8975
• Device Catalogue Number: 9400 ALARIS SYSTEM MANAGER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown