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

Model Number 2420-0007

Device Problems Stretched (1601); Deformation Due to Compressive Stress (2889); Material Distortion (2977)

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

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

The customer reported ballooning of the silicone segment of the tubing, which caused alarms and error codes on the pump.The tubing was replaced; there was no harm reported.

Manufacturer Narrative

The customer¿s report of a bulge/balloon in the silicone segment below the upper fitment was confirmed.Visual inspection showed that the silicone segment tubing had a slight bulge, discoloration, and was weakened near its upper portion just below the upper fitment.Functional testing was unable to replicate the ballooning.The root cause for the reported bulge/balloon in the tubing could not be determined.

• 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5756876
• MDR Text Key: 48402652
• Report Number: 9616066-2016-00842
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 16047293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• 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