MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ACCESS; SET, BLOOD TRANSFUSION

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

It was reported that an access set tubing connector cracked and separated at the spike.This occurred when the new two unit bag of packed red blood cell was being spiked, and blood leaked at the disconnection area.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The actual device was not available; however, a photograph of the sample was provided for evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The actual device was not available; however, a photograph of the sample was provided for evaluation.Photographic inspection revealed the tubing was separated from the spike.It could not be determined that the sample was a baxter product.As the product code is unknown, there is insufficient evidence to verify the reported problem.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4565408
• MDR Text Key: 5549280
• Report Number: 1416980-2015-08617
• 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: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2015

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 03/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: SIGMA SPECTRUM LVP; PACKED RED BLOOD CELL BAG