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

Model Number	C24103E
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An unspecified tubing concern was reported.The as-received set sample was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.None of these were observed it was identified during inspection that there was a bulge along the silicone segment.Further handling of the observed bulge area noted it felt softer/weaker as compared to the rest of the silicone segment.No other issues were observed with the set sample.Since the observation of the bulge in the silicone segment has already been observed in a high number of previously investigated complaints, functional testing was not conducted for this failure.Previous investigation have found that a bulge can occur when an iv push medication or flush is executed below the pump without first clamping the tubing above the injection port.This action was found to result in excessive pressure within the silicone segment thus causing the silicone segment to bulge.The root cause for the source of the excessive pressure is unknown.
Event or Problem Description
It was reported that there was an unspecified tubing concern.It was not known if the event occurred during infusion or priming of the iv set.The customer provided a photo of the iv tubing.Although requested, there is no further patient or event information available.

• 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: 9480918
• Report Number: 9616066-2019-03673
• Device Sequence Number: 17176120
• Product Code: FPA
• UDI-Device Identifier: 07613203021371
• UDI-Public: 7613203021371
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 08/27/2019

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: C24103E
• Device Catalogue Number: C24103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1