MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE PUMP

Model Number 4000

Device Problems Device Alarm System (1012); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Information received a smith medical syringe infusion pumps|medfusion 4000 pumps complaint of base not responding and constant battery depletion alarm was not validated or verified.Physical condition of the device revealed top case cracked by the front left bottom and left rear corners.No visible contamination was visually observed.Event log history revealed base not responding/depleted battery alarm found in ehl several times, however during testing using biomed diagnostic, the complaint was not verified.Battery read normal reading at 97%.Unable to determine cause of event and therefore preventative action was taken to replace interconnect board and battery.Other routine maintenance included on repair summary: replaced damaged top case, right plunger case and battery door.Cleaned, greased and calibrated the device, performed power up process, occlusion test and all functional tests which passed.Returned l-bracket with the pump.Device passed all functional and delivery testing after repairs.

Event Description

Information received a smiths medical pumps|medfusion 4000 pump base not responding / constant battery depleted alarm.No patient involvement as event occurred during testing.

• Brand Name: MEDFUSION
• Type of Device: SYRINGE PUMP
• 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: david halverson ; 6000 nathan lane north; clinical asset management; minneapolis, MN 55442
• MDR Report Key: 10556056
• MDR Text Key: 207607534
• Report Number: 3012307300-2020-09528
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 10610586040818
• UDI-Public: 10610586040818
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K41386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2020

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 Operator: No Information
• Device Model Number: 4000
• Device Catalogue Number: 4000-0101-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1