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

Model Number	2429-0500
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Patient age and dob requested but not provided.
Event or Problem Description
It was reported that a balloon developed in the silicone segment.
Additional Manufacturer Narrative
The customer¿s report that a balloon developed in the silicone segment was confirmed.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 bulge (1.4650 inches long,.7600 inches wide), located 1.6855 inches below the ring retainer of the upper fitment (p/n tc10008721).Clear liquid was observed inside both of the set¿s tubing and the drip chamber.No other anomalies were observed on the set during visual inspection.Functional was performed by placing the infusion set in an alaris pump module and closing the door, programming/running the infusion, pausing the infusion, and then injecting an iv push fluid bolus through a distal y-site of the infusion set.Testing included injecting an iv push bolus after clamping the tubing (below the pump segment but above the iv push site per the dfu) and injecting the iv push bolus without clamping the tubing.Ballooning was not replicated in any clamped testing but has been replicated in unclamped testing when the tubing had been visually observed to be compromised (from previous ballooning).Three samples of the silicone segment were analyzed and the walls were found to be concentric.The root cause for the source of the excessive pressure is unknown.
Event or Problem Description
It was reported that a balloon developed in the silicone segment in the oncology department.The customer later stated that the event occurred during priming with normal saline and there was no patient involvement.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8718960
• Report Number: 9616066-2019-01622
• Device Sequence Number: 2523164
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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
• Operator of Device: Health Professional
• Device Model Number: 2429-0500
• Device Catalogue Number: 2429-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1