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

Model Number MZ1000

Device Problems Occlusion Within Device (1423); Device Operational Issue (2914)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Manufacturer Narrative

The model#/catalog# identified in model #/lot # is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is mz1000-07.The 510k number provided in this report is for the domestic similar product.Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the logs/device be received for evaluation.

Event Description

The customer reported that during a vasoactive infusion, the patient's blood pressure became unstable (both hypotensive and hypertensive), which they observed was due to the needless connector "interfering with the medication delivery".After they removed the mz connector from the infusion circuit, the labile blood pressure was resolved.There was no report of patient harm.

• Brand Name: MAXZERO NEEDLELESS CONNECTOR
• 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: 7578463
• MDR Text Key: 110379794
• Report Number: 9616066-2018-00705
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: MZ1000
• Device Catalogue Number: MZ1000
• Device Lot Number: 16088072
• Other Device ID Number: 10885403224782
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2016
• 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: PRI TUBING
• Patient Outcome(s): Other