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

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 developed a balloon in silicone segment was confirmed by visual inspection of the as-received sample.The set was visually inspected for kinks, incomplete bonding engagements, holes/ tears in the tubing or damages to the components.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.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 developed a balloon in silicone segment.There was no patient harm reported.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• 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: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9197865
• MDR Text Key: 163064792
• Report Number: 9616066-2019-02892
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/24/2019

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 Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2019
• 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