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

Catalog Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2024

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: the charge nurse in labor and delivery reported that once or twice she has been infusing pitocin as a primary infusion, y-sited into a primary infusion of lr.The lr pump module was infusing without alarm, however the pitocin pump module was alarming ¿patient side occlusion¿.We educated her on the proper way to make a y-site connection.Primary tubing.

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.

Event Description

No additional info.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint of flow issues - fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed 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.

• 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: 19056897
• MDR Text Key: 340461549
• Report Number: 9616066-2024-00531
• 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,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2024
• 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: 04/10/2024
• 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