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

Model Number	4000
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation results: one medfusion pump was returned for investigation in used condition.The bottom case had seal damage and the right plunger case was cracked.There was a check clutch reverse error in the event history log (ehl).The travel course error reported by the customer was replicated.This issue occurred because one of the wires on the position pot broke loose from the position pot rail.The source of this problem was not known.A root cause was not established.The investigator replaced the following components: position pot, also clutch halves (left and right), leadscrew and spring.These components were replaced as a preventative measure.The pump passed all the functional tests following these repairs.
Event or Problem Description
It was reported that the device displayed a travel course error.No patient injury or complications were reported in relation to this event.

• Brand Name: MEDFUSION
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10806252
• Report Number: 3012307300-2020-11224
• Device Sequence Number: 11579995
• Product Code: FRN
• UDI-Device Identifier: 15019517070750
• UDI-Public: 15019517070750
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: 4000-0106-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1