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

Model Number 4000

Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

One smiths medical medfusion pump was returned for analysis with crack on the lower left front corner and right plunger case.Event log history was performed and indicated that no error was found relating to the customer's reported problem.During analysis, all the readings of position were found to be within the required specifications, accuracy tests, syringe delivery tests were performed which passed.Pump was operating as intended.Based on the evidence, the complaint was not confirmed, and no fault was found.

Event Description

Information was received indicating that during use, a smiths medical medfusion pump was over infusing.No patient consequences were reported.No adverse effects were reported.

• Brand Name: MEDFUSION
• Type of Device: PUMP, INFUSION
• 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; minneapolis, MN 55442
• MDR Report Key: 10504402
• MDR Text Key: 205991360
• Report Number: 3012307300-2020-09076
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 15019517069624
• UDI-Public: 15019517069624
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• 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: 08/20/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1