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

Model Number 2420-0007

Device Problems Stretched (1601); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2020

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.Although requested, patient information was not provided.

Event Description

It was reported that when the pump alarmed and was inspected, a "swollen area was found in the chamber near the top of the tubing" set.There was no patient harm.No further information was provided.

Manufacturer Narrative

The customer¿s report of a tubing bulge at the top of the silicone pump segment was confirmed.Visual inspection observed that the bulge in the silicone segment was directly underneath the upper fitment.Further visual inspection under magnification found the walls of the silicone tubing segment to be concentric.The device history record for set model 2420-0007 lot 20033326 shows the set was manufactured on 17mar2020 with a total of (b)(4) units.There were no quality notifications issued during the production build of this set.Previously investigated complaints for this same failure mode determined that the ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.

Event Description

It was reported that when the pump alarmed during a normal saline infusion and was inspected, a "swollen area was found in the chamber near the top of the tubing" set.There was no consequence or impact to the patient.No further information was provided.

• 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: 10130048
• MDR Text Key: 194482798
• Report Number: 9616066-2020-01844
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• 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: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2023
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 20033326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100, 8015, 250 ML ICU MEDICAL BAG, TD (B)(6)2020