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

Model Number 2420-0500

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.

Event Description

It was reported that the iv infusion pump began to alarm.When the nurse opened the device's door, the tubing's pump segment burst.

Event Description

It was reported that the iv infusion pump began to alarm.When the nurse opened the device's door and attempted to "massage" the tubing the pump segment split.

Manufacturer Narrative

Patient information requested, however not provided by the customer.The customer's report that the tubing's pump segment split was not confirmed, however a separation at the pump segment to the upper fitment was found.Visual inspection as received observed a separation between the silicone pump segment and upper fitment.Functional testing could not be performed due to the set's separation and obvious leaking that would occur due to the separation.Dimensional analysis was performed and the values measured were all within specification.The root cause of the separation could not be determined.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9050757
• MDR Text Key: 158619128
• Report Number: 9616066-2019-02585
• Device Sequence Number: 1
• Product Code: FPA
• 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
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2022
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: 19076218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015, 8100, TD (B)(6) 2019