MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MZ5307

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd maxzero multi-fuse pressure rated extension set was damaged.The following information was received by the initial reporter:.Situation/background: lines are being primed and hung on patients with central lines per unit protocol.There have been four instances that air has been found in the line after it has been running.One baby decompensated immediately and needed resuscitative measures and 24 hours later went to emergency surgery due to nec from lack of blood flow (air) getting to baby.One baby had perfusion changes on half side of its body and recovered.Two other babies the air was caught before it reached the patient.When the baby is in a swing that is on the ground, the filter stays with the baby, but this is typically when we are getting air in lines.Our process looks normal for what we've always done and been educated; but what else would be causing the air in the line based on the infant's location relative to pumps since the filter is remaining with her? assessment: after thorough investigation of the products and how lines are hanging, the best guess is it is the max zero minibore bi-fuse pressure rated extension set (ref mz 5307).If the medication tubing that connects to the bi-fuse is not screwed on correctly air is getting into the line.This product has been in use for several years and the situations that this has happened in are with experienced nurses who have been using this product.If the tubing connection is not pushed down hard enough and twisted the connection is not tight.There is variation in how nurses connect these and historically has not caused any problems.When the baby is in a swing that is on the ground, the filter stays with the baby, but this is typically when we are getting air in lines and lose prime.Our process looks normal for what we've always done and been educated; but what else would be causing the air in the line based on the infant's location relative to pumps since the filter is remaining with her?.

• Brand Name: BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18584313
• MDR Text Key: 333824780
• Report Number: 9616066-2024-00070
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230608
• UDI-Public: (01)10885403230608
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ5307
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1