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

Model Number 2420-0500

Device Problems Stretched (1601); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The customer¿s report a bubble formed in the tubing was confirmed by pressure testing.During visual inspection clear liquid was observed inside both the set¿s tubing and drip chamber.No bulges or ballooning were observed in the silicone tubing (p/n 12088541) during inspection.No ballooning was observed in the silicone segment during an infusion with a lab pump module and pcu, or with an iv push.Pressure testing replicated the ballooned pump segment.The balloon/bulge was caused by excessive pressure within the silicone segment.The root cause for the source of the excessive pressure was unknown.

Event Description

It was reported a bubble formed in the silicone segment of the tubing while the nurse was trying to place the tubing in the pump after priming.The bulge was noticed after the door would not close correctly.There was no patient harm.

Event Description

It was reported a bubble formed in the silicone segment of the tubing while the nurse was trying to place the tubing in the pump after priming.The bulge was noticed after the door would not close correctly.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
• MDR Report Key: 8983885
• MDR Text Key: 157184563
• Report Number: 9616066-2019-02541
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: 7613203012430
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2022
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: 19076219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 10ML BD SYRINGE, TD UNK; 10ML BD SYRINGE, TD UNK