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

Catalog Number JC7751

Device Problem Filling Problem (1233)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a y-type blood/soln set had a flow issue.This was identified during priming.When the intravenous (iv) line was spiked into the iv solution, it ran freely.However, when the bag of blood was spiked, sluggish flow was observed; blood filled the upper portion of filter chamber.It was further reported that an upstream occlusion was observed on the spectrum iv pump.The tubing was replaced and the blood ran at an appropriate rate on the pump.There was no patient involvement.No additional information is available.

• Brand Name: BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10734660
• MDR Text Key: 213043207
• Report Number: 1416980-2020-06638
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: JC7751
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1