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

Catalog Number 2477-0007

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the bd¿ alaris pump module infusion set there was hole punctured in the tubing causing leakage.The following information was provided by the initial reporter: we have received report for our clinicians of defective alaris blood tubing.The event was described as ¿priming blood tubing with saline using the bd alaris pump infusion blood set.The tubing set had a hole punctured in the tubing and saline was leaking out of the tubing¿.

Manufacturer Narrative

Followup mdr submission for device evaluation: no product or photo was returned by the customer.The customer complaint that there was a hole in the tubing that caused a leak could not be verified due to the product not being returned for failure investigation.A device history record review for model 2477-0007 lot number 22115221 was performed.The search showed that a total of (b)(6) units in 1 lot number was built on 14nov2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.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 it was reported that while using the bd¿ alaris pump module infusion set there was hole punctured in the tubing causing leakage.The following information was provided by the initial reporter: we have received report for our clinicians of defective alaris blood tubing.The event was described as ¿priming blood tubing with saline using the bd alaris pump infusion blood set.The tubing set had a hole punctured in the tubing and saline was leaking out of the tubing¿.

• Brand Name: BD¿ ALARIS PUMP MODULE INFUSION 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17901600
• MDR Text Key: 325469996
• Report Number: 9616066-2023-02019
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019460
• UDI-Public: (01)07613203019460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

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: 2477-0007
• Device Lot Number: 22115221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2022
• 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