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

Catalog Number FNC1154N

Device Problems Improper Flow or Infusion (2954); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tubing of two blood solution sets were splitting at the junction and air was getting in.This issue was identified during setup and prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added: one (1) device was not received for evaluation; therefore, a device analysis could not be completed.One (1) device was received for evaluation; however, only a partial set was returned.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed, and no issues were noted.The reported condition was not verified.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.

• Brand Name: INTERLINK SYSTEM
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• 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: 9795122
• MDR Text Key: 182293265
• Report Number: 1416980-2020-01225
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

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: FNC1154N
• Device Lot Number: 18H30T499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 04/02/2020
• Supplement Dates FDA Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1