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

Catalog Number UNKNOWN

Device Problem Complete Blockage (1094)

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

Event Date 01/10/2024

Event Type  malfunction  

Event Description

It was reported that unspecified bd infusion set was occluded the following information was received by the initial reporter with the following verbatim: during the morning meeting, (b)(6) bmet, advised that a few of the new devices that were installed in 2023 have come to biomed for air-in-line alarms.None of these alarms were able to be duplicated by the biomed engineering team.These were general errors, no specific information available and no devices will be returned.No patient harm reported.No other reported concerns with the alaris devices since their instillation around april 2023.Intensive care unit (b)(6), rn ,stated that she has experienced air-in-line alarms with and without visible air noted in the iv tubing and will try to troubleshoot to resolves.No additional information available.No patient harm reported.(b)(6), rn, stated experiencing patient side occlusion alarms when patient has an iv placed in their antecubital or when the roller clamp is left in the closed position.No additional information provided.No patient harm reported.Outpatient infusion clinician reported difficulty getting the iv tubing to prime with glass bottles.No additional information provided.No patient harm reported.Cpc reviewed spiking a glass bottle with clinician.3rd floor medical surgical (b)(6), rn, stated she had a secondary infusion that was possibly azithromycin that was infusing and then noticed drops coming from the primary container.She then extended the hanger and then drops were noted from the secondary container only.She wasn¿t sure why the infusion would pull drops from the primary infusion instead of the secondary.No additional information provided.No patient harm reported.Cpc reviewed secondary setup with clinician.While observing an infusion setup with (b)(6), rn, she noticed that a secondary medication had the roller clamp in the closed position and the medication container had fluid in it.She then programmed the secondary infusion.(b)(6), rn, stated sometimes experiencing air-in-line alarms sometimes without air noted in the iv tubing and sometimes with a microscopic bubble noted in the iv tubing.To troubleshoot he will use a cotton swab and clean the ¿circle¿ behind the pumping segment.No additional information provided.No patient harm reported.Cpc reviewed best practices for reducing air-in-line alarms, location of air-in-line detector and iv set loading.

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• 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: 18641225
• MDR Text Key: 334882839
• Report Number: 9616066-2024-00168
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• 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