MAUDE Adverse Event Report: CAREFUSION ALARIS NON VENTED BLOOD SET; SET, EXTENSION, INTRAVASCULAR

Model Number 2477-0007

Device Problems False Alarm (1013); Failure to Deliver (2338); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.Requested sn/ lot however customer stated: "unknown.".

Event Description

It was reported that the device alarmed ail during a blood infusion programmed at a rate of 120ml/hr.The rn stated that she was unable to administer the blood due to frequent ail alarms, the lvp module was replaced 3 times as well as the tubing replaced 3 times , a new bag of blood ordered however the ail alarms continued.The rn stated that there was no visible air in the tubing when replaced the modules and sets.The icu/stepdown nurse eventually hung the blood to gravity to continue with the infusion.There was no report of patient impact however a delay in patient treatment.An incomplete event date of (b)(6) 2019 provided as customer stated that the event occurred 4 months ago.Although requested there was no additional event details provided by the customer.

• Brand Name: ALARIS NON VENTED BLOOD SET
• Type of Device: SET, EXTENSION, 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: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9521597
• MDR Text Key: 189991043
• Report Number: 9616066-2019-03727
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019460
• UDI-Public: 7613203019460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2477-0007
• Device Catalogue Number: 2477-0007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• 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