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

Model Number 2426-0500

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported noticing a hole 3 inches above the distal injection port of the tubing while infusing ns to a patient.The infusion was stopped while a replacement set was obtained.There was no patient harm.

Event Description

The customer reported noticing a hole 3 inches above the distal injection port of the tubing while infusing ns to a patient.The infusion was stopped while a replacement set was obtained.There was no patient harm.

Manufacturer Narrative

The customer¿s report of a hole in the tubing was confirmed.Visual inspection showed that the pvc tubing had a slice cut 3 inches above the distal smartsite inlet port.Functional and pressure testing confirmed leaking from the cut.The cause of the hole in the tubing was identified as a slice cut in the tubing consistent with damage from a sharp object.

• 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: 7651420
• MDR Text Key: 112764373
• Report Number: 9616066-2018-00954
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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
• Other Device ID Number: 7613203020992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 71