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

Model Number 2426-0007

Device Problem Leak/Splash (1354)

Patient Problem Pain (1994)

Event Date 12/02/2021

Event Type  malfunction  

Event Description

It was reported that while using the bd alaris¿ pump module administration set leaked.The following information was provided by the initial reporter: "pain medication was leaking from the air vent all night long".

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

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 administration set leaked.The following information was provided by the initial reporter: "pain medication was leaking from the air vent all night long".

Manufacturer Narrative

Follow up mdr for device evaluation.No product or photo was returned by the customer.The customer complaint of leakage from air vent could not be verified due to the product not being returned for failure investigation.A device history record review for model 2426-0007 lot number 21055903 was performed.The search showed that a total of 86,403 units in 1 lot number was built on (b)(6) 2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.We understand and acknowledge that the failure of the 2426-0007 set caused harm to both the patient and caregiver.We are truly sorry for this and fully acknowledge that it happened.Our policy is to collect the tubing sample or a picture/video of the failure whenever circumstances allow, as it enables us to conduct the most thorough investigation possible, but we understand it was not available for this incident and we apologize if the wording in our letter may have been interpreted to mean the incident didn¿t occur.Your feedback is valuable, and we¿ll work to change the wording of our investigation letters to ensure clarity.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.

• Brand Name: BD ALARIS¿ PUMP MODULE ADMINISTRATION 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 ; 8015296192
• MDR Report Key: 13122431
• MDR Text Key: 286345445
• Report Number: 9616066-2021-52662
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403227996
• UDI-Public: 50885403227996
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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 Expiration Date: 05/15/2024
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 21055903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2021
• 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