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

Model Number 2426-0500

Device Problem Material Separation (1562)

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

Event Date 08/02/2022

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 experienced the infusion set in two separate pieces.The following information was provided by the initial reporter: rn was preparing a chemotherapy iv line, opened the package for the infusion set and the line was in two separate pieces.

Manufacturer Narrative

H6: investigation summary: the customer reported the set was separated out of the bag, and returned one 2426-0500 set.The sample was separated at the outlet of the smart site, and the complaint is verified.The root cause of the separation is attributed to shallow insertion depth of the tubing.The tubing had evidence of solvent and passed dimensional analysis.The tubing was clearly not pushed in far enough.No other failure modes observed.Device history record review for model 2426-0500 lot number 22053002 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10may2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion experienced the infusion set in two separate pieces.The following information was provided by the initial reporter: rn was preparing a chemotherapy iv line, opened the package for the infusion set and the line was in two separate pieces.

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15331769
• MDR Text Key: 305494021
• Report Number: 9616066-2022-01260
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: 37613203021006
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

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 Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: 22053002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2022
• 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