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

Catalog Number MMC9609L

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number - the customer reported a potentially associated lot number, 18k13t426.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a blood set did not flow during a blood transfusion.The reporter stated that about twenty minutes after the start of the transfusion, the patient went for a computed tomography (ct) scan.During the scan the roller clamp on the set was closed.Following the scan the roller clamp was reopened and the transfusion was recommenced.About half an hour later, the nurse noticed the transfusion was not flowing through the administration set (no drops evident in the chamber of the admin set).The set was disconnected from the patient.Further inspection of the set revealed that large clots were evident in both chambers of the set.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Lot number provided: 18k13t426.The device was received damaged.Due to the nature of the sample the reported condition was not possible to identify during visual inspection nor could functional testing be performed.Therefore, the reported problem could not be verified or refuted.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: BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - MALTA; marsa
• MDR Report Key: 9030685
• MDR Text Key: 160315049
• Report Number: 1416980-2019-05006
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MMC9609L
• Device Lot Number: 18K13T426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RED BLOOD CELLS, VASCATH