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

Model Number 2426-0007

Device Problems Device Displays Incorrect Message (2591); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer¿s complaint of the balloon in the silicone segment was confirmed per picture received from the customer.It was observed per picture received that the silicone segment tubing had a ballooned bulge near the upper portion of the upper fitment.The root cause for this event could not be determined.

Event Description

The customer reported a bulge in the pumping segment of the set installed in channel a.This module had been infusing ns at kvo but was then turned off to run an infusion on channel b; the line was not clamped.Vidaza was administered on channel b at an unspecified rate via a short primary set that was connected to the primary set in channel a at the port just below the pump.When the vidaza administration was complete in channel b, channel a was then turned on to infuse a normal saline flush and it immediately alarmed for a channel error.When the nurse opened the pump door of channel a, ballooning was noted in the pumping segment just below the upper fitment.It was reported that no iv push had been given prior to the channel error, no pressure bags were used, the patient¿s central line gave a positive blood return, and all clamps were checked and unclamped before pressing start.There was no patient harm.

• 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: 7234756
• MDR Text Key: 98847719
• Report Number: 9616066-2018-00111
• 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
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Other Device ID Number: 10885403227998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: No
• 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: (2)8100, 8015, PRI TUBING, CENTRAL LINE, TD UNK