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

Further clarification from the customer on (b)(6) 2017 determined that this event was initially reported in follow up 1 of report 9616066-2016-01548.The customer¿s report of a bulge/balloon in the silicone segment below the upper fitment was confirmed.No issues were observed during visual inspection but tactile examination found that the silicone segment tubing was weakened on its upper portion just below the upper fitment.Functional testing was performed; slight bulging was observed during priming and the gravity run.The set was then inserted into a pumping module and programmed to run at a rate of 125 ml/hr.The set ran for one hour with no alarms noted.Additional functional testing was performed by attaching a lab 10ml syringe filled with water to the distal smartsite to perform an iv push.An iv push was performed first by occluding the tubing above the injection port per (b)(4) iv push tip sheet, and then again by not occluding the tubing.No bulge/balloon was observed in either case when the device door was opened.The root cause of the silicone segment bulge was not identified.

Event Description

The customer reported a ballooned pump segment noted at the beginning of an infusion.The set was replaced and there was no patient harm.The customer has stated the description and event date provided was interpreted from other sources not provided to carefusion/bd and may not be completely accurate.

• 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: 6298820
• MDR Text Key: 66449804
• Report Number: 9616066-2017-00159
• 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: other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/02/2017
• 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
• Treatment: (B)(4),(2)ORANGE SWAB CAPS, TD: UNK