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

Catalog Number 2420-0007

Device Problem Defective Component (2292)

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

Event Date 01/06/2024

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 smartsite infusion set was damaged the following information was received by the initial reporter with the following verbatim: rcc received a complaint via phone.Pir attached.Hole in tubing.

Event Description

No additional info.

Manufacturer Narrative

It was reported that there was a hole in the tubing.One sample model 2420-0007, lot 23105557 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with water and a leak was observed at the top of the silicone segment.Upon visual inspection under a microscope a pinhole was seen at the top of the silicone segment.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the root cause is unknown.Although the root cause was unable to be determined, a new automatic machine was validated on (b)(6) 2024, which has a vision system that can detect types of failures such as the one reported in this complaint, among others.A device history record review for model 2420-0007 lot number 23105557 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13nov2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• 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: 18701094
• MDR Text Key: 335297248
• Report Number: 9616066-2024-00236
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: (01)07613203021012
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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: 2420-0007
• Device Lot Number: 23105557
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1