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

Model Number 2426-0007

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Patient's demographics requested, but was not provided.

Event Description

It was reported that during an infusion of normal saline (600ml / 75c/hr.), the pump module while connected to the patient alarmed air-in-line.When the nurse opened the door, she noticed the line had a large bulge below the upper fitment.There was no patient impact.

Event Description

It was reported that during an infusion of normal saline (600ml / 75c/hr.), the pump module while connected to the patient alarmed air-in-line.When the nurse opened the door, she noticed the line had a large bulge below the upper fitment.There was no patient impact.

Manufacturer Narrative

The customer¿s report that the line had a balloon below the upper fitment was confirmed by visual inspection of the as-received sample.The balloon was located on the silicone tubing below the upper fitment of the pump segment.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.The customer¿s report that the pump module alarmed for air-in-line was not confirmed.The root cause of the customer¿s experience was not identified because no air-in-line alarms or visual air-in-line boluses were replicated during functional testing.The device pump and pcu that were in use at the time of the customer event were not returned for investigation a device history record for model: 2426-0007 with lot number: 20026609 was performed.The search showed that a total of (b)(4) units were built in 1 lot on 20feb2020.The search showed that there were no quality notifications for the failure mode reported by the customer.

• 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: 10155574
• MDR Text Key: 195249682
• Report Number: 9616066-2020-01882
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2023
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 20026609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100, TD 01/01/2020