MAUDE Adverse Event Report: ST PAUL MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMG; PUMP, INFUSION

Model Number 4000-0106-01

Device Problem Failure to Cycle (1142)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.No product information has been provided to date.

Event Description

It was reported that a system failure occurred.No patient injury was reported.

Manufacturer Narrative

H6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.Visual inspection and functional test were performed.Visual inspection found the device top case was cracked/chipped.Contamination was also visible.Review of the event log found evidence of error messages.Upon function testing, the reported problem could not be duplicated.The root cause is unknown.The speaker was replaced as a preventative measure.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.

• Brand Name: MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMG
• Type of Device: PUMP, INFUSION
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15225684
• MDR Text Key: 304908950
• Report Number: 3012307300-2022-15372
• Device Sequence Number: 1
• Product Code: FRN
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

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: 4000-0106-01
• Device Catalogue Number: 4000-0106-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1