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

Model Number 2420-0007

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s report that a bubble was discovered in the silicone tubing was confirmed.During inspection it was observed that the silicone segment tubing had a bubble starting at the ring retainer of the upper fitment.The set was visually inspected for kinks, incomplete bonding engagements, holes/ tears in the tubing or damages to the components.During inspection it was observed that the silicone segment tubing had a bubble.No other anomalies were observed on the set during visual inspection.Clear liquid was observed inside both the set¿s tubing and the drip chamber.Functional testing was performed and showed no anomalies.The balloon is caused by excessive pressure within the silicone segment.The root cause for the source of the excessive pressure was not definitively determined.

Event Description

It was reported that after the rn noted the pump alarming, and upon checking the tubing, it was noticed the set had a "balloon" in the pumping segment.It was also confirmed that there was no patient harm as a result of this event.

• 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: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9187673
• MDR Text Key: 162877645
• Report Number: 9616066-2019-02843
• 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: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• 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
• 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