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

Model Number 4000

Device Problem No Flow (2991)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

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.The pump alarmed for completed infusion, but the volume was still in the syringe.There was no reported adverse event.

Manufacturer Narrative

Other, other text: b5: updated with additional information.H6: patient code updated reflect code 4582.

Event Description

It was further reported that the event occurred on 23 february 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.

• Brand Name: MEDFUSION
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11679412
• MDR Text Key: 245829395
• Report Number: 3012307300-2021-03217
• 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?: No
• 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: 3 DA
• Patient Weight: 3