MAUDE Adverse Event Report: ST PAUL MEDFUSION 3500 PUMPS; PUMP, INFUSION

Model Number	3500-0600-82
Medical Device Problem Codes	Failure to Charge (1085); Battery Problem (2885)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was showing maintenance battery depleted, will not stay on even when connected to power supply.Tried new power supply.No patient injury reported.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
One infusion pump was received for evaluation.Visual inspection found the tamper seals are both broken.The device was observed to have a chipped top case and cracked right plunger case.The devices event history log was reviewed for evidence of the reported event, low and depleted battery messages, along with maintenance is recommended, was found in the log.To conduct functional testing of the device a battery test was performed.Upon testing, it was revealed the reported problem was duplicated.The cause of the issue was due to the battery that was unable to take a charge.The battery was replaced and reset maintenance is recommended.The device then passed all functional testing.The product is beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a dhr review was not performed.Service history review identified this device has not been in for service previously.

• Brand Name: MEDFUSION 3500 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: 16765101
• Report Number: 3012307300-2023-04269
• Device Sequence Number: 6105630
• Product Code: FRN
• UDI-Device Identifier: 10610586043017
• UDI-Public: 10610586043017
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/11/2023

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: 3500-0600-82
• Device Catalogue Number: 3500-0600-82
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/11/2023
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2020
• 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