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

Model Number 20350E

Device Problems Backflow (1064); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); Underdose (2542)

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.

Event Description

It was reported that tubing leaked/splashed.Prior to observing the leak, the nurse observed fluid on the bedding and patient's clothes and believed it was a result of incontinence.The patient's clothes and bedding were changed.Fluid was also noted on the floor and cleaned by the nurse in her chemotherapy gown, gloves and surgical mask.Later, during an administration of paclitaxel, blood was seen back flowing into the filter.The fluid was "spirting" from the connection point of a primary tubing and extension set.The paclitaxel infusion was attached via secondary tubing to the primary line.Dextrose 5% in water was infusing in the primary line.There was no patient harm.The patient did not receive the dose of paclitaxel; however, it was noted this was not expected to cause significant impact on the disease progression.It was reported that no visible crack or other deformities were visible.Although requested, no additional patient information was provided.

Event Description

It was reported that the tubing leaked and/or splashed.Prior to observing the leak, the nurse observed fluid on the bedding and the patient's clothes and believed it was a result of incontinence.The patient's clothes and bedding were changed.Fluid was also noted on the floor and cleaned by the nurse in her chemotherapy gown, gloves and surgical mask.Later, during an administration of paclitaxel, blood was seen back flowing into the filter.The fluid was "spirting" from the luer lock connection of the filter extension set.This extension set was attached to a primary line while the paclitaxel infusion was attached via secondary tubing to the primary line.Dextrose 5% in water was infusing in the primary line.There was no patient harm.The patient did not receive the dose of paclitaxel; however, it was noted this was not expected to cause significant impact on the disease progression.It was reported that no visible crack or other deformities were visible.It was confirmed during follow up that there was no delay in patient care, and that this event did not contribute to, or result in a serious adverse impact to patient.

Manufacturer Narrative

The customer's report that fluid was squirting out from the luer lock connection of the filter extension set was confirmed based on the customer provided video.The video shows fluid squirting out from the set's female luer lock component.However, no set samples or devices were received for evaluation.The root cause was not identified.The device history record for model 20350e lot 19117133 shows the set was manufactured on (b)(6) 2019 with a total of 6,603 units.There were no quality notifications issued during the production build of this set.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9986276
• MDR Text Key: 193617273
• Report Number: 9616066-2020-01376
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012256
• UDI-Public: 7613203012256
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

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 Expiration Date: 11/29/2022
• Device Model Number: 20350E
• Device Catalogue Number: 20350E
• Device Lot Number: 19117133
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEC TUBING, PRI TUBING, 8100, 8015,TD: (B)(6) 2020.