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

Catalog Number MMC2071B

Device Problem Particulates (1451)

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

Event Date 03/03/2014

Event Type  malfunction  

Event Description

It was reported that an administration set for blood and blood components had particulate matter within the neck of the filter chamber.This was identified during patient infusion.There was no patient injury or medical intervention reported.No additional information is available.

Manufacturer Narrative

(b)(4).(b)(6).A batch review will be performed.  if any relevant information is obtained that is related to the reported event, a supplemental report will be submitted.The sample is reported to be available for evaluation.If the sample is received or additional relevant information becomes available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).It was reported that the particle was identified after use, not during infusion as originally reported.Evaluation: baxter received one sample for evaluation.Visual inspection revealed a yellowish particle in the neck of filter chamber right prior filter.An infrared (ir) scan was performed on the particle and showed that the main component of the particle was polyester, which is consistent with the material of the filter.The particle was further analyzed and was confirmed that it might be generated during the welding process of the chamber filter.The cause was determined to be due to machine or equipment at the manufacturing facility.Action will be taken due to this event and awareness of this issue will be given to the operators.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 - MALTA; a47 industrial estate; malta b; marsa ; MT
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; malta b; marsa ; MT
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3699057
• MDR Text Key: 4332988
• Report Number: 1416980-2014-09858
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2014

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: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: MMC2071B
• Device Lot Number: 13F13V792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2014
• Initial Date FDA Received: 03/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2013
• 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