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
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	01/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bd maxzero multi-fuse pressure rated extension set caused air in line.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?.
Additional 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.

• Brand Name: BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET
• Common Device Name: 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: 18583849
• Report Number: 9616066-2024-00068
• Device Sequence Number: 8203128
• Product Code: FPA
• UDI-Device Identifier: 10885403230608
• UDI-Public: (01)10885403230608
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: MZ5307
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown