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 Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

E.4.Fda notified?: the initial reporter also notified the fda via medwatch # mw5116969.H.3.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 leaked propofol from the damaged tubing during use.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "multiple sets leaking - 1st report on 4/16, second report on 4/19, and 2 more verbal reports from nursing on 4/20 - good catches and interventions by nursing.The other 2 were verbals from nursing to house supervisor and then to me without details other than leaking tubing (not at the connection sites).Could you please clarify where exactly the leakage is taking place with the product in these events?: in the tubing itself.Were you able to identify if the product is leaking because of a damaged component or more of a loose connection?: damaged component.Was there any patient impact/harm in these events? if so was there any need for any medical intervention or treatment?: prior to finding leaking tubing different medications started for blood pressure dropping (once tubing replaced original medication restarted).Prior to finding leaking tubing on second one patient waking up from sedation meds not infusing.Able to correct.Was treatment able to resume and be completed in these events?: yes.Was any medication used with the product? if yes, what was the medication?: levophed was running with the first reported.Propofol was running with the second reported incident.Were there any concerns when priming the sets?: no".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for evaluation? yes.D10: returned to manufacturer on: 28-jun-2023.H6: investigation summary 2 used sample (model#2426-0007) were returned for quality investigation by the customer.It was reported by the customer that the extensions tubing sets have been leaking.Prior to functional testing the sets were visually examined for defects and abnormalities.No other defects or abnormalities were observed.The set were connected to a 10 ml bd syringe filled with water and attempted to be flushed by pressure test.The fluid pass through the sample shows the leakage from the tubing.The leakage from tube was clearly observed because of hole in it was verified in magnification.Leakage issue could be replicated.The quality notification was sent to the plant.A device history record review for model 2426-0007 and lot number 23039059 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.After investigation, the potential root cause of damage tubing was not found to be related to the manufacturing process.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set leaked propofol from the damaged tubing during use.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "multiple sets leaking - 1st report on 4/16, second report on 4/19, and 2 more verbal reports from nursing on 4/20 - good catches and interventions by nursing.The other 2 were verbals from nursing to house supervisor and then to me without details other than leaking tubing (not at the connection sites).¿ could you please clarify where exactly the leakage is taking place with the product in these events? in the tubing itself.¿ were you able to identify if the product is leaking because of a damaged component or more of a loose connection? damaged component.¿ was there any patient impact/harm in these events? if so was there any need for any medical intervention or treatment? prior to finding leaking tubing different medications started for blood pressure dropping (once tubing replaced original medication restarted) prior to finding leaking tubing on second one patient waking up from sedation meds not infusing - - able to correct.¿ was treatment able to resume and be completed in these events? yes.¿ was any medication used with the product? if yes, what was the medication? levophed was running with the first reported - - - propofol was running with the second reported incident.¿ were there any concerns when priming the sets? no.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17035301
• MDR Text Key: 316305395
• Report Number: 9616066-2023-01051
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• 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,Health Professional,User Facility
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 23039059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• 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