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

Catalog Number 2426-0007

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2024

Event Type  malfunction  

Event Description

It was reported that bd alaris pump module smartsite infusion set separated the following information was received by the initial reporter with the following verbatim: rcc received a complaint via email.Email(s) attached.We have a tubing on a chemo bag just come apart.Luckily, the nurse was in the room and the patient¿s chemo was being flushed and we did not have a spill.The nurse was changing the line over to flush and the tubing came apart and there was not a spill.I have the tubing in my office in a chemo bag but still has keytruda in the line.I do have the packaging of this line with it.Just let me know what you want me to do with it.(b)(6) is entering a safety event because it could have been drug wasted and a spill.We have had another tubing come apart while starting infusion.I am brining it down.It came apart at a different location than the other.Saline was all that was in the line at the time.It has the same number on the package as the previous tubing.We have had 3 recent issues with our primary tubing set, bd#2426-0007.The first issue was condensation in the line with what looked to possibly contain mold.The second issue was tubing disconnecting during a chemo treatment.Today we had another incident with another set where the tubing came apart (in a different place) but with saline this time.Will you please investigate asap and let us know how to proceed? thanks so much, paula chemo incident-lot#(10)23115122 saline incident-lot#(10)23115485.

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

No additional information was provided.

Manufacturer Narrative

The customer reported chemo tubing separated, and returned a photo of material 2426-0007, lot 23115122.The photo was examined and the complaint was verified.The separation occurred at outlet of middle smart site.The physical sample was unable to be returned due to the chemo.(for future reference, bd complaints does accept chemo-contamination, it just goes to a different facility) the manufacturing location found the probable root cause for solvent-based separation to be production personnel do not insert the tube correctly in the solvent dispenser during production process.In response, a quality alert was issued to reinforce and communicate proper procedure to production personnel, and the solvent dispenser was revised under ot (b)(4).Device history record review for model 2426-0007 lot number 23115122 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 17nov2023.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• 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: 18785880
• MDR Text Key: 337516636
• Report Number: 9616066-2024-00322
• Device Sequence Number: 1
• Product Code: FPA
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2426-0007
• Device Lot Number: 23115122
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1