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

Catalog Number	2278-0500
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris pump module blood infusion set had air bubbles and air in line.The following information was provided by the initial reporter with the verbatim: "one of the nurses brought me the packaging for a blood set used in the ed.See pics below.This tubing was set up on an alaris pump, the nurses programmed the pump, hit start and then saw the air in the tubing.This air was not in place when they initially primed the pump.They bled out this air and set up the pump again.The pump was then started and the infusion began, the pump alarmed.The nurses returned to the room and found air in the tubing again.One of the nurses working in the same area had this same thing happen earlier this week but thought it was a singular event.The nurse that sent me these pics had it happen last week.This is a patient safety issue and needs urgent attention".
Additional Manufacturer Narrative
(b)(4) ¿ follow up mdr for device evaluation.Two photos were returned by the customer.It was reported that there was air in line.The returned photos show the tubing with blood and air in the line.The customer complaint can be verified.The root cause of this failure was not identified as no product was returned.A device history record review for model 2278-0500 lot number 23035026 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 03mar2023.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS PUMP MODULE BLOOD 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17687230
• Report Number: 9616066-2023-01842
• Device Sequence Number: 6513083
• Product Code: FPA
• UDI-Device Identifier: 50885403223264
• UDI-Public: (01)50885403223264
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 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
• Operator of Device: Other
• Device Expiration Date: 03/01/2026
• Device Catalogue Number: 2278-0500
• Device Lot Number: 23035026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown