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	07/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Event or Problem Description
Report received stated that the blood bag would not open, it had to be pryed open.
Additional Manufacturer Narrative
The unit was received and inspected.The blood bag was found to be still in the un-deployed position and the line clamp was in the released position.There were no visible signs of damage, tears or holes in the blood bag.To determine the functionality of the returned blood bag the blood bag was compressed to lock it closed in the un-deployed state as it is shipped.The bottom of the blood bag was then triggered to open as stated in the instruction for use (ifu).The blood bag opened without issue to its full capacity.This functionality test was conducted several times without any issues deploying the blood bag, therefore the reported complaint was unable to be determined.A review of the device history records indicates that this lot of blood bags met all 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.The instructions for use (ifu) states users should be familiar with thoracic surgical procedures and techniques before using a chest drain and to please refer to all manufacturers¿ instructions for use, indications, contraindications, warnings and cautions for anticoagulant medications, microemboli filters, i.V.Blood administration sets, blood compatible infusion pumps and pressure infuser devices prior to use with this ats bag.
Event or Problem Description
N/a.

• 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: 7754090
• Report Number: 3011175548-2018-00866
• Device Sequence Number: 173868
• Product Code: CAC
• UDI-Device Identifier: 00650862124507
• UDI-Public: 00650862124507
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2018

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: 01/18/2020
• Device Model Number: 2450
• Device Catalogue Number: 2450
• Device Lot Number: 246248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 119