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

Model Number 2420-0007

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.The patient is an adult.Although requested, patient demographics was not provided.

Event Description

It was reported that the tubing had a balloon in the silicone segment.Bubble was found at the top of the pump segment after air in line alarm.There were no adverse effects caused to the patient from the event.Although requested, additional information was not provided.

Event Description

It was reported that the tubing had a balloon in the silicone segment.A "bubble" was found at the top of the pump segment after an air-in-line alarm had occurred.It was confirmed that there was no harm or adverse effects caused to the patient from this event.Although requested, there has been no additional event information made available to date.

Manufacturer Narrative

The customer¿s report of ballooning was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection observed a balloon in the silicone tubing pump segment near the upper fitment.Further visual inspection under magnification found the walls of the silicone tubing segment to be concentric.Previously investigated complaints for this same failure mode determined that the ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.

• 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: 9913446
• MDR Text Key: 202548133
• Report Number: 9616066-2020-01188
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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: 03/20/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2020
• Patient Sequence Number: 1
• Treatment: 8015,8100, THERAPY DATE UNKNOWN