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 Defective Component (2292)

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

Event Date 03/22/2024

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 was damaged the following information was received by the initial reporter with the following verbatim reporting defective product ¿ ref # (b)(4) / lot # 1023119286.Nurse started pump to infuse and it ran for about 1-2 minutes the was alarming ¿occluded patient side.¿ nurse assessed tubing, opened channel and found a significant bulge in soft portion of tubing.Nurse replaced with new iv tubing reprimed and infusion started again without issues.

Event Description

No additional info.

Manufacturer Narrative

It was reported that the tubing was blocked and a bulge was discovered in the silicone segment.One sample model 2426-0007, lot 23119286 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with water and infused at a rate of 125 ml/hr for 15 minutes.No observation of fluid blockage or ballooning 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 2426-0007 lot number 23119286 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23nov2023.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: 19169950
• MDR Text Key: 341426548
• Report Number: 9616066-2024-00612
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: (01)10885403227998
• 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
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• 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: 23119286
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1