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

Model Number 2420-0007

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No product returned.Because no product was returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.

Event Description

It was reported there was 6 aneurysms found in the tubing sets during infusions.The customer indicated that they do not think the tubing is faulty, but that a module was faulty or nurses were leaving the clamp closed as potential causes for the issue.There was no report of patient harm or to medical staff.

Manufacturer Narrative

B5 re-written.Device history record could not be performed on model 2420-0007 because the lot # for the suspect set was not provided.

Event Description

It was reported that tubing sets ballooned during an infusion of an unspecified fluid.It was noted that upon review of the tubings by the facility¿s biomed manager, it was their belief that the tubing is not at fault and that either they have a faulty module or they have an education issue among staff wherein the clinicians are leaving the tubings clamped during infusion.It was then mentioned that the customers are working internally to address the issue.Although requested, additional information was not provided to date.

• 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: 10095979
• MDR Text Key: 192425909
• Report Number: 9616066-2020-01770
• 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: other
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

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 Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015,THERAPY DATE UNKNOWN; 8100,8015,THERAPY DATE UNKNOWN