MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDFUSION 4000 SYRINGE INFUSION PUMP; PUMP, INFUSION

Model Number	4000-0107-01
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.
Event or Problem Description
It was reported that when the medfusion 4000 wireless pumps are in clinical mode and are in use in the departments, the pumps alarm after the infusion delivery is completed.The first alarm shows the message -system failure: primary audible alarm post-.Immediately after that, another a second alarm shows -system failure: acu watchdog failure-.This problem does not occur every time the pump is used, but has occurred intermittently over the past 3 years (2019-2022).Device was used to replicate the reported issue, however clinical engineering has found that the alarm does not occur in maintenance mode.As an example, from the pharmguard server, it was found that from (b)(6), the acu watchdog failure alarm had occurred a total of 58 times for 11 pumps.Clinical engineering was unable to duplicate problem when simulating clinical mode as well.The root cause is still not identified.Representative from smiths medical was contacted.Representative mentioned that they were aware of the problem and that one possible cause could be water seeping into the speaker box at the bottom of the pump.However, when examined, all pumps were found to be dry with no water seepage.More than 15 pumps are involved.No patient injury was reported.
Additional Manufacturer Narrative
Additional information was received indicating that the total number of events was 57 and not 58 as previously reported.
Additional Manufacturer Narrative
Additional information was received indicating that the total number of events was 57 and not 58 as previously reported.

• Brand Name: MEDFUSION 4000 SYRINGE INFUSION PUMP
• 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: 14280092
• Report Number: 3012307300-2022-07491
• Device Sequence Number: 4874613
• Product Code: FRN
• UDI-Device Identifier: 15019517154313
• UDI-Public: 15019517154313
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup,Followup
• Report Date (Section B): 06/09/2022

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: 4000-0107-01
• Device Catalogue Number: 4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 05/11/2022; 05/11/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/08/2022; 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• 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