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

Model Number 2420-0007

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that in the transplant inpatient unit when the rn was priming the line when the tubing separated from itself at the point of the safety clamp.Multiple packages were opened and the same issue occurred.The customer reported that there was no patient impact, no medical intervention required or intubation necessary.

Manufacturer Narrative

Additional information added to: b.7, and h.6.(device code) and section; b.5.(event description - patient/event information clarified/detailed).The customer¿s report that the tubing separated from itself at the point of the safety clamp was confirmed on five of the six returned sets.Visual inspection and functional testing observed separations at the engagements between the lower fitments and distal tubing.Closer inspection of the separated tubing under a lab microscope observed insufficient solvent at the end of the tubing.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.A dimensional analysis was performed on each of the separated tubing.The outer diameter of the tubing was measured and observed to be within specification(s).Functional testing was performed and no leaks or issues were observed.Slight tugging was performed on each of the component¿s engagements throughout the set but no separations or issues were observed.The root cause were identified as a manufacturing issue for insufficient solvent being applied at the engagements of the tubing due to equipment and/or operator error.

Event Description

It was reported that in the transplant inpatient unit when the nurse was priming the line, the tubing separated from itself at the point of the safety clamp.Multiple packages were opened and the same issue occurred.It was confirmed during follow up, that there was no patient impact, nor any medical intervention required or intubation necessary.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMIN, INTRAVASCULAR.
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9717638
• MDR Text Key: 190037530
• Report Number: 9616066-2020-00530
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2022
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 19123083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1