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

Catalog Number 2426-0007

Device Problem Leak/Splash (1354)

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

It was reported that bd alaris pump module smartsite infusion set was leaking the following information was received by the initial reporter with the following verbatim: rcc received a complaint via email.Email(s) attached.U.S.Food & drug administration] describe the event or problem: intravenous line (iv) tubing was leaking and new iv bag was almost empty.-------------------------------------- what was the original intended procedure? : insulin infusion.

Manufacturer Narrative

E4.The initial reporter also notified the fda on nov, 2023.Medwatch report # mw2600320000-2023-8219 h.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 2426-0007 because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

Event Description

No additional info.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE 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: 19043563
• MDR Text Key: 340125417
• Report Number: 9616066-2024-00524
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: (01)10885403227998
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

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: 2426-0007
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 114 KG