MAUDE Adverse Event Report: CAREFUSION MAXZERO EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MZ8003

Device Problem Fluid/Blood Leak (1250)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 05/24/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: mz1000-07; baxter 100ml infusion bag 0.9% sodium chloride injection usp, lot p341446, exp apr17; 5ml bd single use syringe 0.9% sodium chloride, lot 605511b, exp 23feb2019; therapy date: (b)(6) 2016.The customer¿s report of a leak at the filter was not confirmed.Visual inspection showed no obvious damages or issues.Functional testing resulted in no leaking.The root cause of the reported leak at the filter was not identified.

Event Description

The customer reported a leak from the filter of an iv set during a nipride infusion, dosage and rate not specified.The patient became hypertensive with maps reading 130 and "multiple prn drugs" were given before the leak was discovered and the tubing was changed; there was no patient harm.

Event Description

The patient's blood pressure returned to baseline and there was no patient harm.It was noted there was a crack observed in the brown nipride syringe tubing where it connects to the maxzero cap.

• Brand Name: MAXZERO EXTENSION 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: 5844577
• MDR Text Key: 51110343
• Report Number: 9616066-2016-01012
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143234
• 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,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MZ8003
• Device Catalogue Number: MZ8003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2016
• 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