MAUDE Adverse Event Report: ST PAUL MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP; PUMPS, INFUSION

Model Number	4000
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported that device had issues with interconnect board.Tamper seals were removed, top and bottom cases are in excellent condition with no visible contamination.Performed power up process, backup audible alarm post found in ehl.Problem was with main pc board.Found missing component.Customer caused the problem.Replaced main pc board, performed power up and self test process.
Event or Problem Description
It was reported that the device had interconnect board damages.No patient injury was reported.

• Brand Name: MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP
• Common Device Name: PUMPS, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13510046
• Report Number: 3012307300-2022-03176
• Device Sequence Number: 20161499
• Product Code: FRN
• UDI-Device Identifier: 15019517070750
• UDI-Public: 15019517070750
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/10/2022

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
• Device Model Number: 4000
• Device Catalogue Number: 4000-0106-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2015
• 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