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

Model Number C24101E

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

No product will be returned per customer.The customer¿s complaint could not be confirmed because the product was not sequestered and will not be returned for failure investigation.The root cause of this failure was not identified.

Event Description

Received a copy of the customer's medwatch report from the fda which states, "called emergently to bedside of patient with acute change in perfusion/hemodynamic status.Head ct performed with findings of cortical venous air consistent with air embolism.Patient is now stable but remains critically ill.Later evaluation of representative product used for patient demonstrates that filter on the tubing will empty on inlet side then allowing air to enter into tubing by "back priming" the filter with fluid distal to filter.Patient likely received a minimum of 3ml of air.It is unknown exactly how long the patient received air.Iv access was a picc in a scalp vein.Location confirmed on x-ray and estimated catheter tip location svc/ra junction.(please note this patient has a mixing cardiac lesion so flow will shunt from right to left).Iv pump did not alert with air in line as filter was below pump.Iv pump is carefusion alaris pump and was not pulled out of service since filter bypasses pump." the customer reported that on (b)(6) 2017 at 1833 tpn 20.25ml/hr was initiated; lipids were also infusing at an unspecified rate.The filter was primed lying horizontally on a sterile drape.The level of the device was above the patient.The customer reported that it was unknown if there was any disability or lasting effects.

• 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: 6549036
• MDR Text Key: 74550593
• Report Number: 9616066-2017-00727
• 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: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C24101E
• Device Catalogue Number: C24101E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• 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
• Treatment: (B)(4),PRI TUBING,PICC,THERAPY DATE (B)(6) 2017
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 6 DA