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

Model Number 2420-0007

Device Problem Stretched (1601)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The customer¿s report that the tubing set developed a balloon in the silicone segment was confirmed.During inspection it was observed that the silicone segment tubing had a bubble starting 2.6130 inches below the ring retainer of the upper fitment.Clear liquid was observed inside both the set¿s tubing and the drip chamber.No other anomalies were observed on the set during visual inspection.Three samples of the tubing were analyzed and the walls were found to be concentric.Since the observation of the balloon in the silicone tubing segment has already been observed in a high number of previously investigated complaints, functional testing was not conducted.The probable cause identified from previous extensive failure investigations have found that bubble/ balloon can occur when an iv push medication or flush is executed below the pump without first clamping the tubing injection port.This action was found to result in excessive pressure within the silicone segment thus causing the silicone segment to bubble/ balloon.Clinical advice for an iv push medication or flush is to be executed below the pump and clamping the tubing above the injection port.The root cause for the source of the excessive pressure is unknown.

Event Description

It was reported that the tubing set developed a balloon in the silicone segment.There was no patient harm reported.

• 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: 9195096
• MDR Text Key: 162877696
• Report Number: 9616066-2019-02879
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/19/2019

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 Expiration Date: 06/15/2022
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 19066202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2019
• 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