MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK SYSTEM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C6401

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The actual device was not available; however, two (2) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing, including under water pressure testing, was performed and no leakage or blockage was observed.The reported condition was not confirmed on the returned companion samples.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 three (3) interlink system solution sets would not flow during use with sodium chloride.It was further reported that the end of the tubing was kinked.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: INTERLINK SYSTEM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10167691
• MDR Text Key: 195581206
• Report Number: 1416980-2020-03431
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412002118
• UDI-Public: (01)00085412002118
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C6401
• Device Lot Number: SR19B18095
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2020
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: SODIUM CHLORIDE