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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd alaris pump module smartsite infusion set had check valve malfunctioned the following information was received by the initial reporter with the following verbatim: we¿ve had another check valve failure here at comox valley hospital.O when the lower clamps are closed on the iv line and the roller clamp on the secondary line is opened, fluid will drip from the secondary bag and the drip chamber on the primary bag fills up.

Event Description

No additional info.

Manufacturer Narrative

It was reported that there was back flow.Two sample model 2420-0007, lot 23105522 was returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were primed with water and a secondary set attached to the proximal smart site was primed with blue dye water.An infusion run at a rate of 125 ml/hr for 1 hour was performed for both sets.No observation of back flow was observed.The customer complaint was unable to be replicated the root cause could not be determined because the issue could not be replicated.A device history record review for model 2420-0007 lot number 23105522 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10nov2023.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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18935133
• MDR Text Key: 338754321
• Report Number: 9616066-2024-00436
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: (01)07613203021012
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K221327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2024

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: 2420-0007
• Device Lot Number: 23105522
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1