MAUDE Adverse Event Report: ATRIUM MEDICAL BLOOD BAG, ATS SELF-FILLING; APPARATUS, AUTOTRANSFUSION

Model Number	2450
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up once the evaluation is completed.
Event or Problem Description
Auto transfusion blood bag was already activated or ¿sprung¿.
Additional Manufacturer Narrative
The device was not returned for evaluation therefore the complaint could not be confirmed.The device history records associated with this lot were reviewed and found to be complete and have met all finished good specifications.Clinical evaluation: the chest drain auto-transfusion system is used to collect autologous blood from the patient¿s pleural cavity or mediastinum for reinfusion purposes in postoperative and trauma blood loss management.If a unit does not function as intended there is a risk to the patient that needs transfusion to now need type and cross of donor blood products and an increase in the risk of exposure to foreign blood borne pathogens.For models equipped with an inline connector, use of an atrium in-line ats bag will provide an additional method for post-operative ats collection.The instructions for use (ifu)2 state do not use if device or package is damaged.

• Brand Name: BLOOD BAG, ATS SELF-FILLING
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8328795
• Report Number: 3011175548-2019-00170
• Device Sequence Number: 1789672
• Product Code: CAC
• UDI-Device Identifier: 00650862124507
• UDI-Public: 00650862124507
• Combination Product (Y/N): N
• Initial Reporter State: IN
• PMA/510(K) Number: K883663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 2450
• Device Catalogue Number: 2450
• Device Lot Number: 238124
• Device Age: YR
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1