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

Model Number 11448964

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

It was reported tubing disconnecting at the hub when normal saline was pushed through.There was no report of patient impact, delay or serious injury.

Event Description

It was reported tubing disconnected at the hub and attached to one used 500ml baxter bag, vancomycin 1.5g added to 0.9% sodium chloride injection.There was no report of patient impact, delay or serious injury.

Manufacturer Narrative

Correction to sections d.1, d.4, and g.5.Cont¿d from d.11: 100ml baxter bag, lot: p396879, exp: sep21, 5% dextrose injection-curos cap attached to each smartsite; 500ml baxter bag, lot: y307884, exp: aug20, vancomycin 1.5g added to 0.9% sodium chloride injection, lot: v1 5 110519, exp: 02/03/2020 -curos cap attached to distal smartsite.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Manufacturer Narrative

The customer¿s report that the tubing disconnected was confirmed.The set was received with a separation at the engagement between the drip chamber and tubing components.Inspection of the separated tubing end observed insufficient to no solvent traces and evidence that the tubing was not fully inserted into the outlet spigot of the drip chamber.Dimensional analysis of the separated tubing was observed to be within specification.The root cause is due to a combination of factors related to insufficient solvent and improper assembly due to equipment and/or operator error.

Event Description

It was reported tubing disconnected at the hub and attached to one used 500ml baxter bag, vancomycin 1.5g added to 0.9% sodium chloride injection.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.

• Brand Name: ALARIS SECONDARY ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9531410
• MDR Text Key: 190979850
• Report Number: 9616066-2019-03715
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019460
• UDI-Public: 7613203019460
• Combination Product (y/n): N
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

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: 11448964
• Device Catalogue Number: 11448964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/26/2020; 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2420-0007, THERAPY DATE UNKNOWN