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

Catalog Number 10942011

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd alaris pump module infusion set was damaged the following information was received by the initial reporter with the following verbatim: we had another faulty straight tubing infusion set today.It¿s the bd alaris pump infusion set, ref (b)(4).I saved the product and the packaging, but basically at the point indicated below once we primed the tubing with fentanyl it started spraying out because there was a hole in the tubing.This is not the first time this has happened, but is one of the first times i¿ve been able to catch it we have another set of tubing that broke today (12/22).This one was lower in the tubing, but it is cracked and we had to get new tubing as a result.

Manufacturer Narrative

Correction: there were two lot numbers provided by the customer.The information for each additional lot number is as follows: d4.Medical device lot #: 23095855 d4.Medical device expiration date: 09/22/2026 h4.Device manufacture date: (b)(6) 2023 investigation results: no product or photo was returned by the customer.The customer complaint of cracks and brakes in the tubing set could not be verified due to the product not being returned for failure investigation.Device history record review for model 10942011 lot number 23095855 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Device history record review for model 10942011 lot number 23095856 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2023.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.This incident has been added to our database of reported incidents.

Event Description

No additional information.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18531749
• MDR Text Key: 333252264
• Report Number: 9616066-2023-02535
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232404
• UDI-Public: (01)10885403232404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

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: Other
• Device Catalogue Number: 10942011
• Device Lot Number: 23095856
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1