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

Catalog Number 2C8720

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Two single use devices have been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

This report summarizes 2 malfunction events.It was reported that two clearlink y-type blood/solution sets leaked from an unspecified location.This occurred before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information: two single-use devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components were found to be correctly placed and per specifications, and no separations between the components was observed.Pressure testing and clear passage testing under water were performed for both devices with no issues noted.The reported condition was not verified or the returned devices.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: 8015327
• MDR Text Key: 125601270
• Report Number: 1416980-2018-06896
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412049083
• UDI-Public: (01)00085412049083
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 2C8720
• Device Lot Number: R18F08075
• Initial Date Manufacturer Received: 09/30/2018
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: 12/31/2018
• Supplement Dates FDA Received: 01/30/2019
• Type of Device Usage: N
• Patient Sequence Number: 1