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

Model Number 2426-0007

Device Problem Leak/Splash (1354)

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

Event Date 09/29/2021

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 disconnected while changing the iv.The following information was provided by the initial reporter: "tubing broke in half during iv change.It looks like it disconnected at a connection point where the tubing that fits inside the pump connects to the rest of the tubing (one blue connection).".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-18.H6: investigation summary a sample was received and tested by our quality team.The separation was immediately noticed and the customer's complaint of separation has been verified.Visual analyses using microscope was then employed to determine the root cause of this failure.This type of separation (broken retaining ring) is usually caused by an improper loading technique.Indentation of silicone portion was observed to establish that a retaining ring was in fact fastened on set at production.A device history record review for model 2426-0007 lot number 21069026 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 21jun2021.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 set tubing disconnected while changing the iv.The following information was provided by the initial reporter: "tubing broke in half during iv change.It looks like it disconnected at a connection point where the tubing that fits inside the pump connects to the rest of the tubing (one blue connection).".

• 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: 12712636
• MDR Text Key: 278821492
• Report Number: 9616066-2021-52322
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403227996
• UDI-Public: 50885403227996
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/30/2021

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: 06/21/2024
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 21069026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 11/30/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2021
• 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