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

Model Number 2420-0007

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Venipuncture (2129); Therapeutic Response, Increased (2272)

Event Date 01/31/2019

Event Type  Injury  

Manufacturer Narrative

The customer¿s report of an overinfusion of argatroban was confirmed.Unregulated flow was observed on the returned primary administration set (model 2420-0007).The event disposable was evaluated and found to be out of specification.Rate accuracy testing performed shows the non-concentricity (between inside diameter (id) and outside diameter (od) to have a direct impact on the rate accuracy performance.The root cause of the overinfusion of argatroban was an out of specification silicone tubing of the pumping segment of the event primary administration set.

Event Description

It was reported that the primary infusion of argatroban 50mg/50ml (glass bottle) infusing at a rate of 8.4ml/hour, infused faster than expected and was completed within one hour of initiation on an adult patient.The devices were sequestered and found to be operating appropriately, and the programming by the end user was verified to be correctly entered.The patient experienced a higher than expected ptt/inr lab values and required additional lab work and monitoring, however there was no lasting harm to the patient from the event.

• 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: 8652172
• MDR Text Key: 146467792
• Report Number: 9616066-2019-01505
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• 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: 03/28/2019
• 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): Required Intervention