MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SMARTSITE GRAVITY SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 47177E

Device Problem Material Separation (1562)

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

It was reported that bd alaris smartsite gravity set separated.The following information was received by the initial reporter with the verbatim:it was reported that bd alaris smartsite gravity set separated.Here are the photos of the iv lines that seemed to be disconnected when we tried to prime them.So far there have been three iv lines that were affected.We saved the last one and it is currently in our (b)(6).The dates were: oct.16, oct.17 and oct.24.There was no harm that came to any patients.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

No additional information was provided.Material#:47177e, batch#:22029199.It was reported by customer that the iv lines that seemed to be disconnected when we tried to prime them.Verbatim: here are the photos of the iv lines that seemed to be disconnected when we tried to prime them.Additional info from customer: so far there have been three iv lines that were affected.We saved the last one and it is currently in our milton office.The dates were: (b)(6).There was no harm that came to any patients.The mailing address of the office where they are is: xxx.

Manufacturer Narrative

It was reported by customer that the iv lines that seemed to be disconnected when we tried to prime them.Two photos and one sample of material 47177e were submitted by the customer for quality evaluation.Inspection of the photos show that the drip chamber separated from the infusion set tubing.Investigation of the sample under magnification indicates that there is an insufficient amount of solvent on both the drip chamber outlet and the tubing that was connect to it.The lack of solvent can allow for the separation of tubing from the drip chamber to occur without much force.The customer complaint of separation was verified by inspection.A trend for the drip chamber separation issue has been identified for this product line.The appropriate personnel have been notified of this complaint.We have funded a project to examine how to further increase the robustness of the disposable device and prevent future occurrences of this type.As part of the action plan, changes to the solvent dispenser are in the process of being implemented.Customer complaint trends will also continue to be evaluated on a monthly basis.A device history record review for model 47177e lot number 22029199 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 01feb2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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.

• Brand Name: BD ALARIS SMARTSITE GRAVITY SET
• 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: 18086485
• MDR Text Key: 327608142
• Report Number: 9616066-2023-02159
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403235434
• UDI-Public: (01)50885403235434
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K820278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 47177E
• Device Lot Number: 22029199
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1