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

Model Number	4000-0106-231
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported the device had a bad battery and needed a new one.No patient injury/involvement reported.
Additional Manufacturer Narrative
Device evaluation: one device was returned for analysis in used condition.Visual inspection showed the pump was in good condition.Review of the event history log showed an occurrence of a "battery not working/battery communication timeout" error message.Functional testing duplicated the reported issue during power-up.The investigation determined that the battery pack not operating as intended was the cause of the reported issue.The battery pack was replaced to correct the issue.Service history review showed no evidence of an issue related to the complaint within the review period.

• Brand Name: MEDFUSION 4000 PUMPS
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17117541
• Report Number: 3012307300-2023-06181
• Device Sequence Number: 20495370
• Product Code: FRN
• UDI-Device Identifier: 15019517070996
• UDI-Public: 15019517070996
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 09/06/2023

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: Other
• Device Model Number: 4000-0106-231
• Device Catalogue Number: 4000-0106-231
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/28/2023
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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