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

Model Number 2420-0007

Device Problems Fluid/Blood Leak (1250); Stretched (1601)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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

The customer reported that after numerous "occlusion" alarms and an iv restart, the line was flushed to ensure patency.When the flush syringe was removed, the saline began to leak out around the tubing and a bulge was noticed in the silicone segment portion.There was no harm reported.

Manufacturer Narrative

The customer¿s report of a bulge was confirmed.Visual inspection of the set noted that the silicone segment was slightly impaired near the upper fitment.Tactile examination confirmed that the subject area of the silicone segment had been weakened.Functional testing was performed and slight bulging was found during priming and the test gravity infusion.During pressure testing the silicone segment ballooned at a pressure of 20 psi.The root cause for this report could not be identified.

• 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
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5436412
• MDR Text Key: 38219888
• Report Number: 9616066-2016-00179
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR