MAUDE Adverse Event Report: CAREFUSION ALARIS INFUSION SET; SET, INFUSION, INTRAVASCULAR

Model Number 10178573

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2017

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.

Event Description

The customer reported that the patient was returned from operation room with the iv tubing infusing via gravity.The tubing was placed into the iv pump and the pump alarmed "air in line".The tubing was taken out of the pump and an empty syringe was used to draw back the air in the line and then placed back into the pump.The pump then alarmed 3 more times "air in line" before the nurse realized that there was a hole in the tubing.The tubing was disconnected from the patient and new tubing was hung without further complications.There was no report of patient harm.

Manufacturer Narrative

The customer¿s report of a hole in the tubing was confirmed.Visual inspection of the set noted that the silicone segment had a tear near the lower fitment.Examination under magnification showed no crush mark to the upper or lower fitment.Functional and pressure testing confirmed leaking from the silicone tubing near the lower fitment.The root cause of the air in the line was a tear in the silicone segment.The cause of the tear is unknown.

• Brand Name: ALARIS INFUSION SET
• Type of Device: SET, INFUSION, 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7061663
• MDR Text Key: 93206702
• Report Number: 9616066-2017-01534
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10178573
• Device Catalogue Number: 10178573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2017
• 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