MAUDE Adverse Event Report: CAREFUSION NON-VENTED BLOOD SET

Model Number 10015414

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

It was reported that during a blood transfusion, the iv tubing from the blood bag stopped dripping blood into the chamber with 75cc left in the bag to be infused.The tubing set was changed out and the infusion completed without any issue.There was a pall filter in use.The infusion was programmed at a rate of 125cc/hr.For 3 hours.There was no patient impact.

Manufacturer Narrative

Correction: disregard file (after further review, this file is deemed not reportable).

Event Description

It was reported that during a blood transfusion, the iv tubing from the blood bag stopped dripping blood into the chamber with 75cc left in the bag to be infused.The tubing set was changed out and the infusion completed without any issue.There was a pall filter in use.The infusion was programmed at a rate of 125cc/hr.For 3 hours.There was no patient impact.

• Brand Name: NON-VENTED BLOOD SET
• Type of Device: BLOOD SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9525739
• MDR Text Key: 190982650
• Report Number: 9616066-2019-03739
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403233999
• UDI-Public: 10885403233999
• Combination Product (y/n): N
• PMA/PMN Number: K894842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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 Model Number: 10015414
• Device Catalogue Number: 10015414
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR