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

Catalog Number 2432-0007

Device Problem Backflow (1064)

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

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

The customer reported blood backed up, and returned one used sample of material 2432-0007 and lot unknown.The set was visually examined for defects and abnormalities.The blood was observed backed up to about the distal smart site, and the complaint is verified.No leaks or bad connections were found, and the root cause was not found.The potential lots were found from smart site id info.Device history record review for model 2432-0007 lot number 23115085 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13nov2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Device history record review for model 2432-0007 lot number 23115136 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 14nov2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Device history record review for model 2432-0007 lot number 23115152 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15nov2023.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 bd alaris pump module smartsite infusion set had a check valve malfunction the following information was received by the initial reporter with the following : primed ocrevus medication using bd alaris pump infusion set with filter and used alaris iv pump.Connected tubing to patient's piv and started infusion.Blood started flowing back to iv tubing.Stopped infusion.Changed to a new iv tubing and started medication infusion.Medication infusing without problems.We are seeing an increase in defective iv tubing.

• 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: 18938141
• MDR Text Key: 338311280
• Report Number: 9616066-2024-00443
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232327
• UDI-Public: (01)50885403232327
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2432-0007
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Sex: Male