MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD AS LVP 20D 2SS CV - 2420-0007; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2420-0007

Device Problems Stretched (1601); Defective Component (2292)

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

Event Date 03/08/2024

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.B3.The date received by manufacturer has been used for this field.

Event Description

It was reported that bd as lvp 20d 2ss cv - 2420-0007 tubing balooned.The following information was provided by the initial reporter: iron was being infused through this line, pump began to beep high pressure, nurse assessed iv line connected to patient.Noted large "blep" in tubing.

Manufacturer Narrative

It was reported that the tubing ballooned.One photo was taken by the customer that verifies the complaint.The probable root cause for the failure is determined to be a user issue.If the infusion set is not loaded correctly, a ballooning in the pumping segment tubing is possible.The clinical team has been made aware of the issue and can provide additional instructional material for proper loading of the alaris pumps.A device history record review for model 2420-0007 lot number 23105503 was performed.The search showed that a total of (b)(6) units in 1 lot number was built on 08nov2023.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 20D 2SS CV - 2420-0007
• 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: 19005545
• MDR Text Key: 339264218
• Report Number: 9616066-2024-00494
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: (01)07613203021012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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: 2420-0007
• Device Lot Number: 23105503
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2023
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1