MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2420-0007

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.Please note that the customer had initially reached out to bd account executive through email on 21apr2020 reporting the product malfunction.However, bd customer advocacy was not notified of this until the products arrived on 26mar2020 and mdr was promptly submitted with the information made available to customer advocacy at that time.The customer then forwarded the 21apr2020 email correspondence to customer advocacy on 24apr2020.

Event Description

It was reported that the sets were missing a roller clamp.The tubing was not connected to the patient.The issue was discovered at the infusion center.Although requested, additional information was not provided.

Manufacturer Narrative

Correction: disregard file (this file has been determined after clinical review to be non-reportable per our mdr decision document).

Event Description

It was reported that the sets were missing a roller clamp.The tubing was not connected to the patient.The issue was discovered at the infusion center.Although requested, additional information was not provided.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10015080
• MDR Text Key: 189571444
• Report Number: 9616066-2020-01536
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1