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

Model Number 2450

Device Problem Self-Activation or Keying (1557)

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

Event Date 01/29/2019

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up once the evaluation is completed.

Event Description

Auto transfusion blood bag was already activated or ¿sprung¿.

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
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8328795
• MDR Text Key: 136130019
• Report Number: 3011175548-2019-00170
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862124507
• UDI-Public: 00650862124507
• Combination Product (y/n): N
• PMA/PMN Number: K883663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 2450
• Device Catalogue Number: 2450
• Device Lot Number: 238124
• Device Age: YR
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1