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

Model Number SEC TUBING

Device Problem Failure to Infuse (2340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that kepra was not infusing via the secondary line, it was switched out to the primary line.Set up was reviewed by multiple rns and it was correctly done.There was no patient impact.

• Brand Name: ALARIS SECONDARY SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9574987
• MDR Text Key: 191412938
• Report Number: 9616066-2020-00084
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SEC TUBING
• Device Catalogue Number: SEC TUBING
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 75