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

Catalog Number FMC9673

Device Problems Material Deformation (2976); No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was received for evaluation.Visual inspection revealed that the tubing was kinked just under the chamber.Gravity testing was also performed, and solution was found to not flow through the tube under the chamber due to excess solvent causing blockage at the connection of the chamber and the tubing.The reported no flow condition was verified.The cause of the excess solvent was determined to be an operator error during manufacturing.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a blood administration pump set was unable to flow due to a kink in the tubing.This event occurred during priming.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 - TUNISIA; tunis
• Manufacturer (Section G): BAXTER HEALTHCARE - TUNISIA; route de chebbaou; 2021oued e; tunis ; TS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7714524
• MDR Text Key: 114882693
• Report Number: 1416980-2018-04570
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 05413760170107
• UDI-Public: (01)05413760170107
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: FMC9673
• Device Lot Number: 17L16T835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1