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

Model Number 2426-0500

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385); Deformation Due to Compressive Stress (2889)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

It was reported that the nurse was attempting to prime the tubing set when the tubing set was noted to be leaking at the safety clamp.On further review of the tubing set, it was found that there was a kink at the safety clamp that created a hole in the tubing set.The customer further stated that there was no patient involvement.

Event Description

It was reported that the rn was attempting to prime the tubing set when the tubing set was noted to be leaking at the safety clamp.On further review of the tubing set, it was found that there was a kink at the safety clamp that created a hole in the tubing set.The customer further stated that there was no patient involvement.

Manufacturer Narrative

The customer¿s report that the tubing set leaked and was kinked at the safety clamp was confirmed.Visual inspection confirmed a kink on the tubing at the engagement of the lower fitment¿s outlet port.Closer inspection of the kink observed that the tubing was incorrectly inserted into the lower fitment¿s outlet port, with the tubing¿s fluid path opened and not attached at the engagement.No visible damages, holes, or other issues were observed.Functional testing could not be performed due to the separation and the obvious leaking that would occur.The root cause that the tubing set leaked and was kinked at the safety clamp is due to equipment/operator disassembly error that occurred during the manufacturing process.

• 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: 9172853
• MDR Text Key: 161862474
• Report Number: 9616066-2019-02777
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: 7613203020992
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

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: 2426-0500
• Device Catalogue Number: 2426-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1