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

Catalog Number 4C8723

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

This report summarizes 1 malfunction events.It was reported that an unspecified number of clearlink y-type blood/solution sets leaked from the tube during infusion.This involved an unspecified number of patients with no patient consequences.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a photograph of the sample was provided for evaluation.The provided photo did not show a separation between components.The reported event could not be 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: CLEARLINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8021903
• MDR Text Key: 125759468
• Report Number: 1416980-2018-06965
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412049076
• UDI-Public: (01)00085412049076
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 4C8723
• Device Lot Number: R18E26111
• Date Manufacturer Received: 12/31/2018
• Type of Device Usage: N
• Patient Sequence Number: 1