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

Catalog Number	24600-0007
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module smartsite low sorbing infusion set was damaged.The following information was received by the initial reporter with the verbatim: while priming laronidase, fluid began spraying form tubing.Medication sprayed on rn and surrounding environment.Hole found and pressure applied - area taped and tubing bagged to send to central.Pharmacist called rn to request email explaining equipment malfunction in order to make another dose of this enzyme medication.Email sent and safety report completed.
Additional Manufacturer Narrative
E1: initial report facility- (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The customer reported tubing was spraying fluid during priming, and returned one used sample of material #24600-000 and batch #23025395.The sample was visually inspected for defects, and a band-aid was placed on the pumping segment upper fitment.The tubing set was primed with water, and the leak was confirmed to be from a tear in the silicon tubing of the upper fitment of the pump segment.There is a possibility for silicon tears due to improper loading of the pumping segment, we strongly recommend loading the top blue clip into the pump first and then the bottom.Root cause is officially unknown for the issue, but is not related to manufacturing process.Device history record review for model 24600-0007 lot number 23025395 was performed.The search showed that a total of 15,363 units in 1 lot number was built on 23feb2023.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.
Event or Problem Description
No additional information was provided.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET
• Common Device Name: 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: 18240411
• Report Number: 9616066-2023-02293
• Device Sequence Number: 3225217
• Product Code: FPA
• UDI-Device Identifier: 50885403241978
• UDI-Public: (01)50885403241978
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2024

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
• Operator of Device: Other
• Device Expiration Date: 02/20/2026
• Device Catalogue Number: 24600-0007
• Device Lot Number: 23025395
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown