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

Model Number 4000

Device Problems Device Alarm System (1012); No Flow (2991)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

Additional contact: (b)(6).

Event Description

Information was received indicating that a smiths medical medfusion pump did not deliver medication due to the pump alarming "plunger not in place".Three different nurses attempted to load the syringe, but were unsuccessful.The pump was replaced and the replacement pump delivered medication safely.There was no reported adverse event.

Event Description

It was further reported, that the event occurred on (b)(6) 2021.The incident involving, the product malfunction did not necessitate any medical intervention outside of using an alternative medfusion pump to complete the infusions.The medications that were being infused, were not a life-sustaining medications.The incident was described as resolved.The affected pump was not returned to the manufacturer for device evaluation.

Manufacturer Narrative

Device evaluation: one medfusion pump was returned for investigation in good condition.The reported, syringe not in place alarm was evidenced in the event history log (ehl).The alarm was not reproduced, during functional testing.The product complaint was therefore verified, based on the ehl findings.The exhibition of the alarm was attributed to a design issue.This was established as the root cause.The plunger board was replaced to address the reported product problem.

• Brand Name: MEDFUSION
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11679633
• MDR Text Key: 245826548
• Report Number: 3012307300-2021-03218
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 15019517069624
• UDI-Public: 15019517069624
• Combination Product (y/n): N
• PMA/PMN Number: K111386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

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 Operator: No Information
• Device Model Number: 4000
• Device Catalogue Number: 4000-0106-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 DA