MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO CLEARLINK BLOOD RECIPIENT SET; SET, I.V. FLUID TRANSFER

Catalog Number 4C8723

Device Problems Product Quality Problem (1506); Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Lot number - r19c20043 and r19c20142.(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 the paper ties of an unspecified number of clearlink system y-type blood/solution sets were loose and fell off the set.This occurred both prior to patient use and during priming.The staff reported that this had caused several issues including: the line dropping and hitting the floor when the packaging was opened (the set had to be replaced), the line becoming tangled, the set being difficult to hang on the iv pole, lines unraveling and hitting the ground after priming, and the drip chambers becoming inverted during setup, leading to air getting into the line during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information: two (2) single-use devices were received for evaluation.Visual inspection revealed that the paper ties were loose.Functional testing including pressure testing and clear passage testing was performed for both sets with no issues noted.The reported condition of loose paper ties was verified.The cause of the condition was not determined.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, I.V. FLUID TRANSFER
• 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: 8833166
• MDR Text Key: 152535570
• Report Number: 1416980-2019-04068
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• 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: SEE H10
• Date Manufacturer Received: 09/30/2019
• Type of Device Usage: N
• Patient Sequence Number: 1