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

Catalog Number 2C8750

Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was air in the filter of a clearlink y-type blood solution set during infusion, and blood was not flowing through the filter properly.The set was being used with a sigma spectrum infusion pump.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.Visual inspection of the photo did not identify any defects associated with the no flow event.The reported event was not verified.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: 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5171444
• MDR Text Key: 29055969
• Report Number: 1416980-2015-39770
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2015

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
• Device Expiration Date: 12/21/2019
• Device Catalogue Number: 2C8750
• Device Lot Number: DR14L21014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2015
• Initial Date FDA Received: 10/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2014
• 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