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

Catalog Number MZ9270

Device Problem Separation Problem (4043)

Patient Problems Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

Event Type  Injury  

Manufacturer Narrative

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 extension set with needleless connector separated the following information was received by the initial reporter with the following verbatim description of what happened: infant with low blood sugar reading <25.Ivf d10w infusing.Rn noted trifuse separated at the filter.Rn changed trifuse, blood sugar came up with bolus of d10w product # and lot #: mz9270 lot # 22119145.Was the course of treatment altered?: neonate required bolus of d10w to bring blood sugar up.Any harm to the patient?: mild temporary harm.

Manufacturer Narrative

Cancel the mdr task for the pr(b)(4), as this is a duplicate of pr(b)(4).

Event Description

Material#: mz9270.Batch number#: 22119145.It was reported by customer that rn noted trifuse separated at the filter.Rn changed trifuse, blood sugar came up with bolus of d10w verbatim#: rcc received a complaint via email.Email(s) attached.Date of occurrence: 1/4/24.Description of what happened: infant with low blood sugar reading <25.Ivf d10w infusing.Rn noted trifuse separated at the filter.Rn changed trifuse, blood sugar came up with bolus of d10w.Product # and lot #: mz9270 lot # 22119145 was the course of treatment altered?: neonate required bolus of d10w to bring blood sugar up.Any harm to the patient?: mild temporary harm.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
• 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: 18748175
• MDR Text Key: 336780685
• Report Number: 9616066-2024-00273
• Device Sequence Number: 1
• Product Code: FPA
• 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,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ9270
• Device Lot Number: 22119145
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention