MAUDE Adverse Event Report: ST PAUL MEDFUSION; SYRINGE PUMP

Model Number 3500

Device Problems Device Alarm System (1012); Insufficient Flow or Under Infusion (2182)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Information received a smiths medical medfusion 3500 pump was alarming when 8mm of feeds are left.Follow up information revealed no patient involvement or injury.

Manufacturer Narrative

Other, other text: additional information: d5 and e4 are unknown.No information has been provided to date.Device evaluation: the pump was returned for investigation.A visual inspection of the pump found that the factory label was intact and the pump was in good condition with no appearance of physical damage.No error which related to customer reported problem was found in the event log.During functional testing, customer delivery program was performed.Pump operated as intended and no problem was found.The reported failure was not confirmed.The root cause cannot be established.Performed preventative maintenance and all functional testing.Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: MEDFUSION
• Type of Device: SYRINGE PUMP
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; ste 114 w, main rcvng; minneapolis, MN 55442
• MDR Report Key: 10253224
• MDR Text Key: 198189312
• Report Number: 3012307300-2020-07134
• Device Sequence Number: 1
• Product Code: MRZ
• UDI-Device Identifier: 10610586041242
• UDI-Public: 10610586041242
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

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 Model Number: 3500
• Device Catalogue Number: 3500-0600-01
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 07/23/2022
• Supplement Dates FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2019
• 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