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

Model Number 2420-0500

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Age at time of event: elderly.8100 module that also involved in this event was captured in emdr (b)(4).Although requested, no additional information was provided.

Event Description

It was reported that during a 500ml normal saline bolus infusion, the iv tubing set "burst" and leaked.The tubing set was replaced and the infusion was continued.This occurred at outpatient infusion.It was reported that there was no patient harm.

Manufacturer Narrative

The customer complaint of tubing set leak and lvp error code 240.4150 could not be confirmed due to the product was not returned for failure investigation.Device history record for model 2420-0500 lot 19115956 shows that the set was manufactured on 8 november 2019 with a total of (b)(4) units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.The root cause of this failure was not identified as no product was returned.No investigation was performed.

Event Description

It was reported that during a 500ml normal saline bolus infusion, the iv tubing set "burst" and leaked.The tubing set was replaced and the infusion was continued.It was also reported that the large volume pump alarmed for occlusion patient side, which upon maintenance review per the customer, showed error code 240.4150.This occurred at outpatient infusion.It was reported that there was no patient harm.

• 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: 10079758
• MDR Text Key: 196477190
• Report Number: 9616066-2020-01696
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: 7613203012430
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

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 Expiration Date: 11/08/2022
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: 19115956
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015, THERAPY DATE (B)(6) 2020.