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

Model Number 4000

Device Problem Image Display Error/Artifact (1304)

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.

Event Description

It was reported that there was a travel clutch error.No patient injury was reported.

Manufacturer Narrative

Other text: b5: additional information received by smiths medical/icu on 02 june 2022 via email and attached to complaint object: the event occured before the infusion.There was no patient involvement.H6: event problem and evaluation codes: updated.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated h10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device had top case cracked, chipped by the front right and left bottom corners, bottom case cracked by the "l" bracket pole clamp, device was missing battery pack and had a cracked right plunger case.Visible contamination by the tube holder and by the "l" bracket pole clamp.Error was found in the device ehl (event history log) multiple times.The customer stated problem was duplicated.Normal wear of the lead screw and clutch halves.Replaced lead screw, clutch spring and both clutch halves.Power up, self test and performed infusion and occlusion test.Device software upgraded.The cause of the reported problem was traced to components failure.A dhr (device history 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 reported problem were found during the review of service and repair records., corrected data: d4: correction: model number: 4000 h4: correction: device manufacturing date: 27-may-2014.

• Brand Name: MEDFUSION
• 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; douglas; minneapolis, MN 55442
• MDR Report Key: 14570682
• MDR Text Key: 293337302
• Report Number: 3012307300-2022-10416
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586040818
• UDI-Public: 10610586040818
• 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,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• 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: 4000-0101-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1