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

Model Number PRIMARY TUBING

Device Problem Reflux within Device (1522)

Patient Problem Venipuncture (2129)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that on the ortho unit, the patient had magnesium ordered, and the nurse noted it was running at a bolus rate, which was confirmed by another rn.The infusion was then switched to another pump module, but still ran at bolus rate.It appeared that approximately half the bag had infused, but the patient was asymptomatic.A magnesium level was redrawn.The customer reported there was no detectable harm.The customer also reported the tubing was sent out for testing and it was indicated there was failure of the back check valve which caused the appearance of free flow as the medication went into the carrier (primary) fluid.

• 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8233492
• MDR Text Key: 132598637
• Report Number: 9616066-2019-00028
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRIMARY TUBING
• Device Catalogue Number: PRIMARY TUBING
• 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
• Treatment: (2) 8100, SEC TUBING,8 015, TD (B)(6) 2018
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR