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

Model Number 2426-0007

Device Problem Stretched (1601)

Patient Problem No Information (3190)

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s complaint of a balloon in pump segment was confirmed per photo received by the customer.Per the photo a bulge/balloon in the silicone segment tubing near the upper portion of the upper fitment was observed.The root cause for this event could not be determined.Additional patient information: african american.

Event Description

It was reported that the pump segment ballooned.It's unknown if an iv push was administered and if the tubing would have been clamped above the smart site during the iv push.The patient, who was being treated for pancreatis, was receiving lactated ringers at 200 ml/hour.There was no patient harm.

Event Description

Received a copy of the customer's medwatch which stated, "nurse was checking the patency of pt's iv line via flush iv tubing set up in a pump when she opened the door of the pump, she noted there was a balloon in the line tubing was removed and new tubing set up ballooned tubing was not saved for further investigation fda safety report id# (b)(4)" it's unknown if the tubing was clamped above the smartsite during the iv push.

Manufacturer Narrative

Additional information provided from mw5088049.

• 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: 8829378
• MDR Text Key: 152327107
• Report Number: 9616066-2019-02089
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2022
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 19016336
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, TD 5/17/2019
• Patient Age: 58 YR