MAUDE Adverse Event Report: ST PAUL MEDFUSION; 40000

Model Number 4000

Device Problem Device Alarm System (1012)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Investigation completed on a smiths medical syringe infusion pumps|medfusion 4000 pumps.The customers complaint of getting error code was verified as the event log revealed ? travel reverse error - check clutch/plunger lever" and occlusion testing confirmed event.Action was taken to replace the replaced lead screw, clutch spring and both clutch halves.Malfunction was isolated to normal wear as device physical condition revealed top case cracked by tubing guides and corners, cracked bottom case by l-bracket and right plunger case cracked.Device passed occlusion testing once repaired.

Event Description

Information received a smiths medical pumps|medfusion 4000 is alarming an error code.No patient adverse events reported.

Manufacturer Narrative

Other text: additional information was received by smiths medical on 12 march 2021 that the reported problem was found during annual pm testing.

• Brand Name: MEDFUSION
• Type of Device: 40000
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11404880
• MDR Text Key: 234450370
• Report Number: 3012307300-2021-01688
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 10610586043567
• UDI-Public: 10610586043567
• Combination Product (y/n): N
• PMA/PMN Number: K111386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

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: 4000-0105-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1