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

Catalog Number ASKU

Device Problems Material Twisted/Bent (2981); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter postal code:(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was no flow through an unspecified access blood solution set.It was observed that the access set tubing was collapsed and an unspecified baxter pump could not administer cryoprecipitate to a patient due to an alarm of ¿upstream occlusion¿.This event occurred during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Initial reporter postal code:(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was no flow through an unspecified access blood solution set.It was observed that the access set tubing was collapsed and an unspecified baxter pump could not administer cryoprecipitate to a patient due to an alarm of ¿upstream occlusion¿.This event occurred during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to h6 and h10.H10: 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.

• Brand Name: NI
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13595849
• MDR Text Key: 286113675
• Report Number: 1416980-2022-00741
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

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: Other
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 03/03/2022
• Supplement Dates FDA Received: 03/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CRYOPRECIPITATE.; UNSPECIFIED BAG.; UNSPECIFIED BAXTER PUMP.