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

Catalog Number UNKNOWN

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter email address- (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that unspecified bd infusion set over infused.The following information was received by the initial reporter with the verbatim: (b)(6) 2023 - lvp giving frequent air-in-line alarms.Patient could visibly see bubbles in the line.Nurses were trying to get the bubbles out of the line and eventually told the patient "it's okay if a few bubbles get in there."(b)(6) 2023 - same pump as before.Continuing the frequent air-in-line alarms.Nurse told patient "when it alarms like that: just push the reset button."patient had to push the reset button about 40 times this day.Patient requests to have the lvp exchanged and the nurses change it out but the new lvp is also alarming.When these alarms get annoying for the nurse she removed the line from the pump and just let it hang.(b)(6) 2023 - alarms again on the lvp this day the line is back in the lvp.Patient is concerned about this day because the iv bag emptied in about 10 minues instead of the usual hour he was used to.Patient told the nurses he was sick of pushing the reset button and the nurses told him that unfortunately the equipment at this location isn't very well kept by the biomedical engineers.

• Brand Name: UNSPECIFIED BD 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: 18207869
• MDR Text Key: 328968552
• Report Number: 9616066-2023-02263
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• 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