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

Model Number C24103E

Device Problem Stretched (1601)

Patient Problem No Information (3190)

Event Date 08/26/2019

Event Type  malfunction  

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 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
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9480918
• MDR Text Key: 190982542
• Report Number: 9616066-2019-03673
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021371
• UDI-Public: 7613203021371
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1