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

Model Number 20059E-0006

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

20059e-00060/no 510k this is an international code- the model#/catalog# identified is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is 20059e.The 510k number provided is for the domestic similar product.- k960280 the affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

The reported feedback suggests that there was a leakage.The iv fluids (hartmann solution) was disconnected from the 20059e-0006 extension set, blood began to flow back from the patient and leaked from the plug.

Manufacturer Narrative

A visual inspection of the sample confirmed the customer's report that the smartsite was oval in shape; leakage was observed during a flush through.A review of the production records did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Please note, the cause of this issue is exposure of the smartsite® to an external heat source that brings the component temperature above 60°c.A review of the manufacturing process, bd storage conditions, and sterilization process has not found a potential root cause for this level of excess heat.

Event Description

The reported feedback suggests that there was a leakage.

• Brand Name: ALARIS SMARTSITE EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9528328
• MDR Text Key: 202938692
• Report Number: 9616066-2019-03762
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20059E-0006
• Device Catalogue Number: 20059E-0006
• Device Lot Number: 17085853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1