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

Catalog Number 2420-0500

Device Problem Material Separation (1562)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that 2 bd alaris¿ pump module smartsite¿ infusion sets had issues with the pump segment of the tubing separating from the safety clamp.The following information was provided by the initial reporter: "the concern is that when removing the set from the pump, the pump segment of the tubing broke away from the safety clamp.It was mentioned this has happened twice before with 2 different pumps.".

Manufacturer Narrative

One sample model 2420-0500 was returned for investigation.The set was examined for defects and abnormalities.Nothing below the silicone segment was returned.Sample was separated at the bottom of the silicone segment.The customer complaint that the sample separated was verified and a quality notification was sent to the manufacturer.Based on the manufacturer's review of the magnified picture, there is evidence of a correctly assembled silicone segment and since the issue came after removing the set from the pump the issue is not manufacturing related.The most probable root cause is due to pulling on the tubing too hard when removing the set from the pump.A device history record review for model 2420-0500 lot number 23065161 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 14jun2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0500 lot number 23065192 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15jun2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0500 lot number 23065267 was performed.The search showed that a total of 86403 units in 1 lot number was built on 17jun2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17950126
• MDR Text Key: 325920445
• Report Number: 9616066-2023-02108
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012448
• UDI-Public: (01)37613203012448
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2024

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: 2420-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 01/07/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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