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

Catalog Number UNKNOWN

Device Problem Backflow (1064)

Patient Problem Insufficient Information (4580)

Event Date 11/28/2023

Event Type  malfunction  

Event Description

It was reported that unspecified bd infusion set had backflow.The following information was received by the initial reporter with the verbatim: order received to administer ffp via uac.Per protocol, blood component set 48" neonatal with 170 microns filter primed and set up with syringe with extra blue clamp applied in addition to roller clamp being closed, as per units practice change.When attaching to uac, and pump started 5mls over 1 hour per orders, it was quickly noted that blood was flowing back out of baby and into the tubing.Transfusion stopped and tubing clamped, and uac flushed to deliver blood volume back into baby.Medical team notified of issue, and verbal order from attending to give ffp iv push by transport team as they did not want to obtain piv access due to poor skin integrity.Transport team arrived to bedside and drew up ffp that had been filtered using the blood component set into a syringe and used macrobore extension set to deliver ffp per orders via uac using iv pump instead of pushing.No blood flowing back with this method and ffp being delivered via pump over 1 hour.".

Manufacturer Narrative

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: 18298620
• MDR Text Key: 330134730
• Report Number: 9616066-2023-02369
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2023

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
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2023
• 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