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

Model Number 2420-0007

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

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The customer¿s report that the iv tubing issues was confirmed.The reported tubing issue was identified to be a balloon in the silicone pumping segment.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Further visual inspection of the inner diameter of the silicone tubing observed the tubing to be concentric.Functional testing of previous complaints with the failure mode of ¿balloon/bulge in silicone tubing segment¿ was performed by placing the infusion set in an alaris pump module.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 that the tubing was defective.Although requested, there has been no impact to patient response or additional event information made available to date.

Event Description

It was reported that the tubing was defective.Although requested, there has been no impact to patient response or additional event information made available to date.

Manufacturer Narrative

Correction: device evaluated by mfg h3: revised to yes.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMIN, INTRAVASCULAR.
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9990200
• MDR Text Key: 190168383
• Report Number: 9616066-2020-01448
• 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,other
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

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: 03/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1