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

Model Number 2426-0500

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

The product has been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Section requested but not provided.

Event Description

It was reported from unit lakeside 55 that the primary tubing set was infusing via alaris pcu and pump module for less than 24 hours when the tubing set developed a balloon in the silicone segment.The customer later stated that there were no adverse effects caused to the patient from the event.

Manufacturer Narrative

The customer¿s report of ballooning 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.Visual inspection observed a deformation at the top of the silicone pump segment indicating that it had previously ballooned.Further visual inspection under magnification found the walls of the silicone tubing segment to be concentric.Functional testing was not conducted.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.

Event Description

It was reported from unit lakeside 55, that the primary tubing set was infusing via an alaris point of care unit, (pcu) and pump module for less than (24) hours when the tubing set developed a "balloon" in the silicone segment, after the nurse heard the pump alarming.The customer later stated that there were no adverse effects caused to the adult patient from this event.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET,ADMINISTRAION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9630515
• MDR Text Key: 191559290
• Report Number: 9616066-2020-00286
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: 7613203020992
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, TD (B)(6) 2020.