MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SECONDARY SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 11448964

Device Problem Disconnection (1171)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported that the bd alaris¿ secondary set came apart before attaching the bag.The following information was provided by the initial reporter: "we do have a set, (b)(4), that fell apart before we even attached it to the bag.".

Manufacturer Narrative

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

Manufacturer Narrative

The following fields have been updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 03-mar-2023.H6: investigation summary: two samples were received with the customer's complaint of separation.This investigation concerns the verified complaint of 11448964 drip chamber separation.(pr 7519690 will contain the investigation for the other separation in the pump segment upper fitment received.) only a drip chamber was received with the separation complaint but the information is sufficient for the root cause of insufficient solvent during assembly to be determined.The manufacturer is aware of this issue and is making active efforts to eliminate further occurrences of drip chamber separation with this set.A trend for the drip 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 11448964 device and prevent future occurrences of this type.As part of the action plan, changes to the drip chamber to tubing assembly 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 11448964 lot number 22119307 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 17nov2022.There were no quality notifications issued for the failure mode reported by the customer during the 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.

Event Description

It was reported that the bd alaris¿ secondary set came apart before attaching the bag.The following information was provided by the initial reporter: "we do have a set, ref# 11448964, that fell apart before we even attached it to the bag.".

• Brand Name: BD ALARIS¿ SECONDARY 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16449739
• MDR Text Key: 310432453
• Report Number: 9616066-2023-00277
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403234743
• UDI-Public: 10885403234743
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 11448964
• Device Lot Number: 22119307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1