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

Model Number 2420-0007

Device Problems Backflow (1064); Fluid/Blood Leak (1250)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 10/19/2019

Event Type  malfunction  

Manufacturer Narrative

The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Patient age and dob requested but not provided, however, the customer stated that the patient was an adolescent patient.

Event Description

It was reported that the patient experienced blood backing up into iv tubing while receiving dextrose 5% and 0.25% normal saline with 20meq of potassium chloride infusing at 20 ml/hr.Upon review by the bedside rn, a leak was noted at the y-port closest to patient side.The tubing was changed three times between (b)(6), with the same results.It was believed that the leak caused the backup of blood.The blood would clear with flushing but then it begins backing up again.The patient's peripherally inserted central catheter (picc) clotted and required administration of cathflo to dissolve the blood clot.However, picc was ultimately removed due to concern for infection.There was no delay in patient therapy and there was no known deep vein thrombosis (dvt) or infection that has been identified on the patient to date.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• 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: 9312502
• MDR Text Key: 203141832
• Report Number: 9616066-2019-03249
• 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,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/21/2019

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: 11/12/2019
• 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