MAUDE Adverse Event Report: FRESEIUS KABI USA, LLC / FRESENIUS HEMOCARE NETHERLANDS B.V. AT-AUTOTRANSFUSION SET, C.A.T.S. CELL SAVER DISPOSABLE ; APPARATUS, AUTOTRANSFUSION

Model Number AT1 AUTOTRANSFUSION SET

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2020

Event Type  malfunction  

Event Description

Malformation in disposable tubing that caused the instrument to display an error code and stop processing.Required defective disposable to be removed from set and replaced to avoid blood loss.Fda safety report id# (b)(4).

Event Description

Mdr report key: (b)(4).Report number: mw5092201.The correct lot number is idt182, the catalog number is correct.I mistakenly put the lot number for the reservoir in the report.The mfr is aware of this, and they have the disposable involved.

• Brand Name: AT-AUTOTRANSFUSION SET, C.A.T.S. CELL SAVER DISPOSABLE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): FRESEIUS KABI USA, LLC / FRESENIUS HEMOCARE NETHERLANDS B.V. ; lake zurich IL 60047
• MDR Report Key: 9586099
• MDR Text Key: 175201981
• Report Number: MW5092201
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2022
• Device Model Number: AT1 AUTOTRANSFUSION SET
• Device Catalogue Number: 9005104
• Device Lot Number: IDT182
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1