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

Catalog Number 2202-0007

Device Problem Air/Gas in Device (4062)

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

Event Date 03/23/2024

Event Type  malfunction  

Event 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: description as reported : case (b)(4) cust.Lodged multiple complaints re: material 2202-0007.1ea reported as tubing noted to have hole in it when priming lipids.Not used on patient, no harm.1ea reported large amount of air in tubing after going through filter + close to patient.This amount of air could be life threatening to the patient.Occurred while in use with patient, no serious injury/harm done but near miss.

Manufacturer Narrative

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

• Brand Name: BD ALARIS PUMP MODULE 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: 19134751
• MDR Text Key: 341465995
• Report Number: 9616066-2024-00603
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403274039
• UDI-Public: (01)10885403274039
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2202-0007
• Device Lot Number: 23085143
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1