MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL ACCESS; SET, BLOOD TRANSFUSION

Catalog Number 2C8750

Device Problem Improper Flow or Infusion (2954)

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

Event Date 06/11/2014

Event Type  malfunction  

Event Description

It was reported that a clearlink y-type blood solution set back flowed into a blood bag.A 250 ml bag of 0.9% sodium chloride (saline) was used to prime the set from the tubing of one y-site and then clamped off.The blood bag was then connected to the other tubing of the y-site.The set was used with a sigma pump and was to deliver 50 ml of blood an hour for two hours.After two hours the saline bag had 50 ml remaining in it.The blood bag had not emptied and 200 ml of saline had flowed into the blood bag.The pump stated that all 100 ml of solution had been delivered.It was noted that the clamp on the saline line was not as tight as before.There was no patient injury, medical intervention or adverse event associated with this event.No additional information is available.

Manufacturer Narrative

Complaint no: (b)(4).Should additional relevant information become available, a follow-up mdr will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL; parque industrial itabo, zona; haina ; DR
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL; parque industrial itabo, zona; haina ; DR
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3995586
• MDR Text Key: 4778445
• Report Number: 1416980-2014-25909
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993120
• 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: 07/16/2014

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?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8750
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2014
• Initial Date FDA Received: 08/08/2014
• 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