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

Catalog Number	2204-0007
Medical Device Problem Codes	Free or Unrestricted Flow (2945); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2.Patient¿s birthday was not provided, 01-jan-xxxx was used based on age of patient h.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris pump module infusion set had air in line the following information was received by the initial reporter with the following verbatim: verbatim: rcc received a complaint via email.Email(s) attached.During beginning of infusion alarm stated air in line, but when checked no air was visible in line.When tubing changed no alarm sounded.
Event or Problem Description
Material # 2204-0007, batch # unknown.It was reported by customer that during beginning of infusion alarm stated air in line, but when checked no air was visible in line.When tubing changed no alarm sounded.Verbatim: rcc received a complaint via email.Email(s) attached.During beginning of infusion alarm stated air in line, but when checked no air was visible in line.When tubing changed no alarm sounded.Model #: 2204-0007.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of air bubbles / air in line could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 2204-0007 because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.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.

• Brand Name: BD ALARIS PUMP MODULE 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: 19807192
• Report Number: 9616066-2024-01021
• Device Sequence Number: 7525392
• Product Code: FPA
• UDI-Device Identifier: 10885403199363
• UDI-Public: (01)10885403199363
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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 Catalogue Number: 2204-0007
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White