MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FENWAL BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number EMC9675

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during a blood transfusion using a blood component administration set in the neonatal intensive care unit, part of the 3 way tap broke off from the set.This was reported by the customer as, ¿when running blood through the neonatal giving set the 60ml syringe and part of the 3 way tap broke off from the set and the syringe occluded.Customer has to spike the other iv (intravenous) port in the rbc (red blood cell) and obtain as much blood as they could to use for the transfusion.They were only able to transfuse 14ml instead of the 19ml prescribed." a new set was used to continue the transfusion.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4 and h6.H10:the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.The reported condition is not clearly observed via the provided photographs and due to the nature of the returned sample no additional testing could be performed.Retention samples were visually inspected and no issue or damage was observed.The retention samples were gravity and leak tested with no issues noted.The reported problem could not be 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: FENWAL BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10554291
• MDR Text Key: 207553852
• Report Number: 1416980-2020-05806
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): Y
• 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: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EMC9675
• Device Lot Number: 20B22T382
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON BAXTER SYRINGE; RED BLOOD CELLS; NON BAXTER SYRINGE; RED BLOOD CELLS
• Patient Age: 1 MO