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

Model Number MZ1000-07

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problem No Code Available (3191)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: central venous line, therapy date (b)(6) 2018.No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.(b)(4).

Event Description

The customer reported that the patient had milrinone infusing at 0.5 mcg/kg/hr and mivf infusing at 9.5 ml/hr via the central venous line's (cvl) distal port.Shortly after pm shift change, the rn was called to the patient's room for a report of medications leaking all over the bed with a large bloody area on the blankets.The rn was unable to flush the distal port without leakage; the md was notified and tpa was administered through the line.The customer alleges that the maxzero¿ valve is not working correctly and is causing multiple line occlusions and leaks.There was no report of lasting harm caused to the patient.

Event Description

The customer reported that the patient had milrinone infusing at 0.5mcg/kg/hr and mivf infusing at 9.5ml/hr via the central venous line's (cvl) distal port.Shortly after pm shift change, the rn was called to the patient's room for a report of medications leaking all over the bed with a large bloody area on the blankets.The rn was unable to flush the distal port without leakage; the md was notified and tpa was administered through the line.The customer alleges that the maxzero¿ valve is not working correctly and is causing multiple line occlusions and leaks.There was no report of lasting harm caused to the patient.

• Brand Name: MAXZERO NEEDLELESS CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7881031
• MDR Text Key: 120413282
• Report Number: 9616066-2018-01690
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230196
• UDI-Public: 10885403230196
• Combination Product (y/n): N
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,(2)MZ9267,8100,SYRINGE, TD (B)(6); 8015,(2)MZ9267,8100,SYRINGE, TD (B)(6)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 1 MO
• Patient Weight: 4