MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP CLEARLINK SYSTEM Y-TYPE BLOOD TUBING SET; SET, BLOOD TRANSFUSION

Catalog Number 2C8750S

Device Problems Aspiration Issue (2883); No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient was to receive a blood transfusion.The tubing was obtained along with a bag of normal saline to prime the tubing.The saline was spiked and we began to prime the tubing.The drip chamber filled up ok but we could not get the saline to flow past the drip chamber.All clamps were checked and opened.We also tried to aspirate fluid through the end without success.The flow was obstructed somehow and we ultimately had to obtain another set.Manufacturer response for y-type blood solution set, clearlink system (per site reporter): they are sending me shipping material.

• Brand Name: CLEARLINK SYSTEM Y-TYPE BLOOD TUBING SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORP; 911 north davis; cleveland MS 38732
• MDR Report Key: 6215426
• MDR Text Key: 63637540
• Report Number: 6215426
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 2C8750S
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO