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 Backflow (1064)

Patient Problem Insufficient Information (4580)

Event Date 07/18/2023

Event Type  malfunction  

Event Description

It was reported that bd alaris pump module smartsite infusion set had flow issues.The following information was provided by the initial reporter with the verbatim: chemo was hung as secondary.At shift change rn doing handoff noticed chemo was backed up into flush bag and filling into bag.Line was checked and appeared hung correctly.Full bag of chemo followed by the full bag of flush that now contained chemo and finish with a flush behind.No visible issues with tubing noted.Unable to determine cause.What they are being treated for: osteosarcoma.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

No additional info.

Manufacturer Narrative

One used sample model 2420-0007 lot 23035066 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The sample was primed with water and a bd secondary set primed with blue dye water was attached to the needless connector just before the back check valve.The sets were allowed to flow freely using gravity.It was observed that the blue dye water was flowing up the primary set line.The customer complaint that there was back flow was confirmed.A quality notification was sent to the supplier.From the supplier investigation, particulate presence could not be confirmed through visual inspection of the assembled check valve.The check valve was inspected on offline testers and backflow failure was observed.The check valve was disassembled, and particulate was observed on the silicone disc.The particulate was sent to a lab for ftir analysis.The particulate observed between the disc and the sealing surface created a leak path that led to the backflow.Ftir analysis results indicated particulates associated with silicone polymer.This particulate was not generated at the supplier.A notification was sent to the manufacturer.From the manufacturer's investigation, the potential root cause for back flow due to particles in check valve could be related to contamination during the proximal automated machine process generated for the same component.The reported failure mode was addressed under a quality notification: the cleaning of the bowl feeder with vacuum cleaner and alcohol wipes was carried out on (b)(6) 2023.The material of the affected lot was 100% reviewed on (b)(6) 2023.The failure mode will be escalated to the supplier by the sqe team.No further actions are needed.It is difficult to know where in the production process or external processes the check valve became contaminated.A device history record review for model 2420-0007 lot number 23035066 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09mar2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17738519
• MDR Text Key: 323329064
• Report Number: 9616066-2023-01881
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• 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: 01/19/2024

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: 23035066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• 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
• Patient Age: 9 YR
• Patient Sex: Female