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

Catalog Number 10016073

Device Problem Backflow (1064)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported that bd as lvp 20d 2ss cv primary set secondary medication bag backed up into the primary bag.The following information was provided by the initial reporter: it appears that the secondary medication bag back-primed into the primary line.Details: primary line of 500 ml d5w hung on bd pump tubing (non-filtered) infusing well on pump channel (left side of pump) secondary line ¿ medication line ¿ oxaliplatin (cytotoxic medication) ¿ 300 ml of fluid to be infused over 2 hours ¿ pump programmed and infusion started at 150ml / hr.28 minutes into the 2 hour infusion the nurse noted that the oxaliplatin medication bag was almost empty, pump setting at 150ml / hr and volume to be infused shows 230.1 ml remaining.Primary medication bag fuller (drip chamber full) ¿ indicating that medication from the secondary line was back flowing into the primary line.Primary line had been lowered on two hangers line infusing into a portacath.No injury to patient; prolonged chair time required to ensure all medication administered.Secondary line clamped and primary fluid programmed to run over 2 hours (pharmacist involved).

Manufacturer Narrative

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

Manufacturer Narrative

Dhr only no product or photo was returned by the customer.The customer complaint of back flow with primary/secondary setup could not be verified due to the product not being returned for failure investigation.Dhr information run for both the primary and secondary sets.Device history record review for model 2420-0007 lot number 24015096 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12jan2024.Device history record review for model 10016073 lot number 23119104 was performed.The search showed that a total of 21,603 units in 1 lot number was built on 10nov2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of these sets.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

Event Description

No additional information was provided.

• Brand Name: BD AS LVP 20D 2SS CV PRIMARY SET
• 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: 18946962
• MDR Text Key: 339083827
• Report Number: 9616066-2024-00451
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403230118
• UDI-Public: (01)50885403230118
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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: 10016073
• Device Lot Number: 23119104
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1