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 01/28/2024

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: when rn pulled iv tubing out of pump in the usual fashion, the tubing broke apart right above the blue clamp that is inserted into the pump.Product#: 2420-0007.External reference number: (b)(4).

Event Description

No further information was provided.Material#: 2420-0007, lot#: 1023105171.It was reported by the customer reported when rn pulled iv tubing out of pump in the usual fashion, the tubing broke apart right above the blue clamp that is inserted into the pump.Verbatim: rcc received a complaint via phone.Pir attached.When rn pulled iv tubing out of pump in the usual fashion, the tubing broke apart right above the blue clamp that is inserted into the pump.Product#: 2420-0007.External reference number: psr#(b)(4).

Manufacturer Narrative

It was reported by the customer reported when rn pulled iv tubing out of pump in the usual fashion, the tubing broke apart right above the blue clamp that is inserted into the pump.Two photos were submitted for quality evaluation.Evaluation of the samples submitted show that the silicone tubing had separated from the lower pumping segment fitting.The photos do not show if the securement ring was on the assembly before the tubing had separated.The customer complaint of tubing defective / damaged was verified.Based on the investigation of the photos and the description of the failure from the customer, the root cause of the failure could not be determined.If the securement collar was missing from the infusion set, the infusion set would have leaked during infusion, prior to the rn pulling the tubing out of the pump, however, no leakage was reported.In addition the act of removing the tubing from the pump with excessive force may have caused the silicone tubing to separate from the lower pumping segment fitting.Therefore the root cause could not be determined.A device history record review for model 2420-0007 lot number 23105171 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09oct2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 18775347
• MDR Text Key: 336195527
• Report Number: 9616066-2024-00294
• 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: Health Professional
• 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: 23105171
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1