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

Model Number 2420-0007

Device Problem Leak/Splash (1354)

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

Event Date 09/24/2021

Event Type  malfunction  

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 the bd alaris¿ pump module smartsite¿ infusion set tubing was defective and leaked while priming it.The following information was provided by the initial reporter: "we have another faulty tubing from 6ab¿a leak was noted when priming the line.I have the tubing and a 500ml bag of saline that is attached.This was never connected to a patient as the leak was noted when priming the tubing.No medications have infused through this line.".

Manufacturer Narrative

H.6.Investigation: the customer reported a leak in the tubing during priming, and returned one used sample of material #2420-0007 lot #21043386.The sample was clearly leaking from a cut or tear in the silicon near the lower fitment.The edges of the cut were quite jagged and looked to be done inadvertently by a machine sharp edge.The sample was investigated further by the manufacturing team, and they found the root cause to be possible incorrect material handling, edges in the fixtures, part caught in the machine during assembly, or improper method followed.This summer, a quality alert to the root causes was issued and a person was assigned to review the correct use of fixtures.A device history record review for model 2420-0007 lot number 21043386 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of leakage with lot #21043386 regarding item #2420-0007.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set tubing was defective and leaked while priming it.The following information was provided by the initial reporter: "we have another faulty tubing from 6ab.A leak was noted when priming the line.I have the tubing and a 500ml bag of saline that is attached.This was never connected to a patient as the leak was noted when priming the tubing.No medications have infused through this line.".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12674935
• MDR Text Key: 277884467
• Report Number: 9616066-2021-52278
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021020
• UDI-Public: 37613203021020
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

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 Expiration Date: 04/28/2024
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 21043386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• 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