MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD AS LVP BLD180M 15D SS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2477-0007

Device Problem Defective Component (2292)

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

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd as lvp bld180m 15d ss tubing leaked.The following information was provided by the initial reporter: details of complaint (reported issue): i wanted to make you aware of a product defect that we experienced with one of the bd alaris infusion sets.21 feb 2024 iv pump alarmed "air in line" nurse opened channel on iv pump and saw blood had leaked out of tubing.Clamps closed and tubing removed from pump.Nurse was wearing gloves while investigation pump.

Manufacturer Narrative

It was reported that blood was leaking out of the tubing.One sample model 2477-0007, lot 23115170 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with water and an infusion run was started at a rate of 125 ml/hr for one hour.No air in line or leakage was observed.The customer complaint was unable to be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 2477-0007 lot number 23115170 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 16nov2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

Event Description

No additional info.

• Brand Name: BD AS LVP BLD180M 15D SS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 18827135
• MDR Text Key: 337747771
• Report Number: 9616066-2024-00343
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019460
• UDI-Public: (01)07613203019460
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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: Health Professional
• Device Catalogue Number: 2477-0007
• Device Lot Number: 23115170
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2023
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1