MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PHARMGUARD; PUMP, INFUSION

Model Number	22-4075-0301-51
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
When using pharmguard toolbox to transfer of drug library fails, but it can learn pump history successfully.Created and empty library to rule out any conflicting parameter could be causing the transfer to fail, but it still failed.Uninstalled and reinstalled drivers, still failed.After ruling out software issues i determined that it must be a hardware issue and recommended they order a new ir device and cable.No patient involvement.

• Brand Name: PHARMGUARD
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14103813
• Report Number: 3012307300-2022-06323
• Device Sequence Number: 4776061
• Product Code: FRN
• UDI-Device Identifier: 15019517151107
• UDI-Public: 15019517151107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2022

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: 22-4075-0301-51
• Device Catalogue Number: 22-4075-0301-51
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/13/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown