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

Catalog Number JC7790

Device Problems Improper Flow or Infusion (2954); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the upper portion of the filters of three (3) blood sets did not empty and air in the tubing was observed.This issue was identified after completion of patient transfusion.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a companion sample and photograph was received for evaluation.Visual inspection of the unused sample did not identify any abnormalities that could have contributed to the reported condition.All components are correctly placed and according to specifications.A functional test including pressure test and clear passage test was performed on the unused sample with no issue noted.A visual inspection was performed to the photograph using the naked eye which revealed air in line and no flow.The reported condition was verified.By the nature of the sample, no additional tests were performed. the cause of the condition could not be determined.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 CORPORATION; deerfield IL
• MDR Report Key: 10098321
• MDR Text Key: 192491178
• Report Number: 1416980-2020-02983
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412152745
• UDI-Public: (01)00085412152745
• 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: 07/02/2020

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: JC7790
• Device Lot Number: R19K09081
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 06/12/2020
• Supplement Dates FDA Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1