MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number JC7751

Device Problems Backflow (1064); Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a y-type blood/soln set would not allow blood to flow easily and backed up into the top chamber.This occurred during patient use.The intravenous (iv) line was patent.The issue was resolved when the line was changed.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10814036
• MDR Text Key: 215500393
• Report Number: 1416980-2020-06986
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412152738
• UDI-Public: (01)00085412152738
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: JC7751
• Device Lot Number: DR20A24046
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLOOD; BLOOD