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

Model Number 2420-0007

Device Problem Deformation Due to Compressive Stress (2889)

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

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

Customer reported ballooning of the pump segment while in use on a patient.No patient harm reported.

Manufacturer Narrative

Concomitant product: baxter 1000 ml 20 meq potassium chloride injection iv bag, lot # c994004, exp.Apr 2017; therapy date unk.The customer¿s report of ballooning was confirmed.Visual examination revealed 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.Slight bulging was noted during priming and a gravity infusion.No alarms were noted during a test pump infusion.Pressure testing was performed and the ballooning was replicated.The root cause of the balloon in the silicone segment 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5404353
• MDR Text Key: 37308496
• Report Number: 9616066-2016-00213
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 15126211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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