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

Catalog Number VMC9609

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2015

Event Type  malfunction  

Event Description

It was reported that there were clots in a blood set during transfusion of red blood cells.The reporter stated that the patient was approximately 2 hours and 15 minutes into the transfusion when the nurse observed that the unit of blood had stopped running.The nurse then observed clots in the filter chamber and extension below the chamber.The transfusion was immediately discontinued.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Additional information: the nurse reported that the device came from six possible batches: 14a01v237, 13g31v142, 14f30v794, 14k01v462, 15a31v191, 13f27v796.A batch review has been conducted on all six batches.There were no deviations found related to this reported condition during the manufacture of these lots.The possible manufacturing dates are: 14a01v237: 01/29/2014; 13g31v142: 09/23/2013; 14f30v794: 07/15/2014; 14k01v462: 11/10/2014; 15a31v191: 02/15/2015; 13f27v796: 11/10/2014.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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4688045
• MDR Text Key: 5636496
• Report Number: 1416980-2015-16559
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 03/31/2015

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 Catalogue Number: VMC9609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 04/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2015
• 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
• Treatment: UNIT OF RCLD