MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE PUMP

Model Number 4000

Device Problem Device Alarm System (1012)

Patient Problem No Information (3190)

Event Date 09/10/2020

Event Type  malfunction  

Event Description

Information received a smiths medical medfusion syringe 4000 pump just received at site and taken out of box revealed alarm "primary audible alarm post" no patient adverse events reported.

Manufacturer Narrative

Other, other text: additional information: d10, h6, h10: device evaluation: one smiths medical medfusion pump was returned for analysis with the top and bottom cases in an excellent condition and no visible contamination.Event log history was performed and indicated that primary audible alarm post was recorded in history.During analysis, the reported issue was able to be duplicated.It was noted that the speaker was the cause of the reported issue.Service replaced the speaker to correct the reported issue.Service also performed preventive maintenance and all functional testing.Based on the evidence, the complaint was confirmed, and the problem source of the reported event is unknown.

• Brand Name: MEDFUSION
• Type of Device: SYRINGE PUMP
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10613751
• MDR Text Key: 209397346
• Report Number: 3012307300-2020-10017
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 15019517069624
• UDI-Public: 15019517069624
• 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: 12/03/2020

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: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: 4000-0106-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1