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

Model Number 2420-0007

Device Problems Stretched (1601); Deformation Due to Compressive Stress (2889)

Patient Problem Death (1802)

Event Date 09/10/2019

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 1000ml baxter bag, lot y294827, exp 07/2020, 0.9% sodium chloride injection; pressure bag; yellow cap; therapy date: (b)(6) 2019.The customer¿s report that the tubing set developed a balloon in the silicone segment was confirmed.No ballooning/bulge was observed on the silicone segment; however, a portion of the silicone tubing segment beneath the ring retainer of the upper fitment was deformed and more elastic than the rest of the silicone tubing (6295 inches long).Functional testing was performed by using the customer provided iv bag set to prime the set.No issues were observed.Additional testing using a lab 10ml syringe filled with water was used to perform an iv push first using the set¿s distal smartsite.An iv push was performed first by occluding the tubing above the injection port per if2204 iv push tip sheet, and then again by not occluding the tubing.The iv push performed by not occluding the tubing above the injection port observed a balloon on the set.The root cause of the ballooning in the silicone segment was not definitively determined.The probable cause have found that a bubble/ balloon can occur when an iv push medication or flush is executed below the pump without first clamping the tubing injection port.This action was found to result in excessive pressure within the silicone segment, causing it to bubble/ balloon.

Event Description

It was reported that during a code blue on a unit, the tubing set was obtained from the code cart, attached to normal saline 1l, primed and inserted into a pressure bag.The tubing was not clamped.When the nurse inflated the pressure bag, the tubing set developed a balloon in the silicone segment.Of the tubing.Although the customer stated that there was a delay in treatment and the adult patient expired, the customer further stated that the patient's death was not a result of the defective tubing set.

• 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
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9176391
• MDR Text Key: 161918053
• Report Number: 9616066-2019-02813
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death