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

Model Number 2420-0007

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 12/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that 2 safe sets where the plunger had separated from the rubber tip.There is no report that patient care was delayed and that it did not contribute to, or result in serious adverse impact to patient.

Manufacturer Narrative

Additional information added: d.4; d.10, & h.4.*************************************************** the customer's report of ¿separation¿ was confirmed based on visual inspection of the as-received samples.The tubing of both sets were torn completely with the remainder of the torn tubing still bonded within the available smartsite ports.One of the sets also had their tubing torn completely to the expected bottom smartsite port.Functional testing was not deemed necessary due to the damaged tubing.The root cause of the customer's report was identified as due to intentional force being applied to cause the observed damages.

Event Description

It was reported that 2 safe sets separated at the proximal y-site inlet port.There was no report that patient care was delayed and it did not contribute to, or result in serious adverse impact to 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: 9561930
• MDR Text Key: 191264314
• Report Number: 9616066-2020-00026
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2022
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 19085745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1