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

Catalog Number 2C8750

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2014

Event Type  malfunction  

Event Description

It was reported that the second chamber of a clearlink system y-type blood/solution set filled with air and would not drip.The reporter stated that the top chamber was full while the bottom chamber ¿was just sucking air.¿ this occurred during a blood transfusion, when there was approximately 15 minutes left in the procedure.The second lead of the set was not back primed and no saline bag was hung.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).(b)(6).The device is reported to be unavailable for evaluation; however, a photograph of the device was received and will be evaluated.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Evaluation summary: the physical sample was not returned; however, a photograph was provided for evaluation.During photographic inspection, air was identified in the filter and tubing of the device.A review of the directions for use section of the labeling was performed.The cause of the air in the device was unable to be determined.A capa has been opened to further investigate and address this issue.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The cause of the reported no flow was determined to be a use error.It was reported that the unused second lead of the device was not primed.According to the device labeling the user is instructed to prime an unused lead.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 - 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: 3935523
• MDR Text Key: 4572833
• Report Number: 1416980-2014-22647
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2014

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 07/15/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/12/2014; 02/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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