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

Model Number MZ8002

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 100 ml baxter bag ndc 0338-0049-48, lot number: p360305, exp: aug 18; 0.9% sodium chloride and 10 ml bd syringe, ref: 306502, lot number: 635511a, exp: 2019-12-19; 0.9% sodium chloride.Therapy date unknown.The customer¿s report of air in line was confirmed.Visual inspection, including microscopic examination showed no obvious damages or any issues.Functional testing resulted in fluid leaking from the weld area on the pediatric 0.2 micron filter component and inability to fully reprime the set.The root cause of the air in line was a leak at the filter which was determined to be due to a supplier issue.

Event Description

The customer reported an issue with air in line and micro-bubbles with no further information provided.There was no report of patient harm.

• Brand Name: MAXZERO 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: 6895620
• MDR Text Key: 87758627
• Report Number: 9616066-2017-01307
• 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
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ8002
• Device Catalogue Number: MZ8002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• 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