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

Model Number 2426-0500

Device Problems Material Separation (1562); Separation Failure (2547)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer declined to return the product for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that the event occurred at the cardiac cath lab.The iv pump tubing pulled apart at the top of the flexible part of the tubing, above the cassette.Normal saline was running at the time.It was reported that no patient care was delayed and it did not contribute to, or result in serious adverse impact to patient.

Event Description

It was reported from the cardiac cath lab that the tubing set separated from the upper fitment during a normal saline infusion.It was further confirmed during follow up, that there was no patient involvement associated with this event, and subsequently, no patient harm or impact as a result of this event.

Manufacturer Narrative

The customer¿s report that the tubing set separated was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted separation from the inlet port of the distal smartsite below the lower fitment.No separations to the upper fitment were observed.No other abnormalities were observed.Examination under magnification noted that both sides of the tubing had insufficient solvent applied at the engagement.A gap was also observed, indicating that the expected tubing was not fully inserted.Further handling/tug of the rest of the set's tubing engagements observed no separation or any issues.Functional testing was deemed unnecessary due to the separated tubing and the leaking that would occur.Dimensional analysis of the tubing's outer diameter observed to be within specification(s).The root cause of the separation 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 after two hours of normal saline infusion, the tubing set separated from the upper fitment.The event occurred in the cardiac cath lab.There was no consequences or impact to the patient.

• 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: 9513451
• MDR Text Key: 191110343
• Report Number: 9616066-2019-03736
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2019

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 Expiration Date: 11/14/2022
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: 19113097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/03/2020; 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, THERAPY DATE (B)(6) 2019
• Patient Age: 69 YR