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 received in the deployed state.An attempt was made to re-close the blood bag by compressing bag in order to re-latch the spring within the blood bag.When the blood bag was compressed the spring would not re-latch itself.Properly functioning blood bags will re-latch when the blood bag is compressed.Upon further inspection the spring for re-latching the blood bag was found floating within the blood bag.It is not known how the re-latching spring mechanism became broken.The device history records associated with this lot were reviewed and found to be complete and have met all finished good specifications.As the cause of the damage to the spring latch is unknown atrium medical corporation cannot conclude that the damage occurred prior to or after leaving atrium medical corporation for distribution.A review of the device history records show that this lot of ats blood bags passed all quality requirements prior to being released.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.

Event Description

N/a.

• 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: 8327893
• MDR Text Key: 136130418
• Report Number: 3011175548-2019-00169
• Device Sequence Number: 1
• Product Code: CAC
• 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

• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Device Age: YR
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 03/01/2019
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1