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

Model Number 2450

Device Problem Difficult to Open or Close (2921)

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

Event Date 07/29/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Report received stated that the blood bag would not open, it had to be pryed open.

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 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: 7754090
• MDR Text Key: 116594155
• Report Number: 3011175548-2018-00866
• 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: 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
• Device Operator: 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 Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/31/2018
• Supplement Dates FDA Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 119