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

Catalog Number 4C6766

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2014

Event Type  malfunction  

Event Description

It was reported that there was separation with the spike adapter from the filter with an inter-link set.The separation occurred after infusion, while the user was removing the filter from the infused bag.There was patient involvement, but there was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Upon completion of baxter's investigation, if additional relevant information is obtained, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Additional information: a companion sample and photograph of the actual sample was provided for evaluation.The companion sample was visually inspected, leak tested, and a pull test was performed.There were no defects found and the sample primed and flowed normally.The provided photograph of the sample showed spike separation.The customer reported issue is verified based on the photographic inspection.A capa has been opened to address this issue.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; 600 mts oeste de entrada; cartago ; CS
• Manufacturer (Section G): BAXTER HEALTHCARE; 600 mts oeste de entrada; cartago ; CS
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4428484
• MDR Text Key: 5283354
• Report Number: 1416980-2015-02399
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/24/2014

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 Expiration Date: 12/04/2018
• Device Catalogue Number: 4C6766
• Device Lot Number: R13L04128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 01/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2013
• 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: STEM CELL TRANSPLANT BAG