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

Model Number 2420-0007

Device Problem Break (1069)

Patient Problem Air Embolism (1697)

Event Date 11/03/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 500 ml baxter bag oxacillin sodium and dextrose 5%.Two non-bd orange swab alcohol caps.The customer¿s report that the tubing separated at the y-port was confirmed.Visual inspection of the set showed that the vinyl tubing was completely separated from the distal smartsite inlet port with leaking noted.Functional testing was not performed because of the separation.Inspection under magnification showed that both sides of the tubing had insufficient solvent applied at the engagement.Dimensional analysis was performed on the vinyl tubing; the tubing measured within specification.The root cause of the separation was a manufacturing issue of insufficient solvent being applied at the junction of the vinyl tubing and the tubing not being pushed all away into the inlet port.

Event Description

The customer reported that during infusions of oxacillin 12 gm/500 ml at 20.83 ml/hr and argatroban at 8.3 ml/hr, the tubing was noted to be separated at the y port.While ambulating the patient became flushed, diaphoretic and dyspneic.Oxygen saturation was between 65-70% on room air.A code was called and the patient was transferred to the ccu with bipap (bilevel positive airway pressure) support.Stat blood work was performed and an echocardiogram revealed an air embolus in the right ventricle.The tubing was found to be sheared off at the lowest injection port with the remaining tubing attached to the right upper cvc, open to air.

• 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: 7076406
• MDR Text Key: 93510318
• Report Number: 9616066-2017-01549
• Device Sequence Number: 1
• Product Code: FPA
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/01/2017
• 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
• Treatment: 8100,8015, THERAPY DATE (B)(6)
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR