MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DOUBLE DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number	3620-100
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Customer has indicated that the drain they received the tubing was warped/pinched rendering it unable to be used for suction or drainage.
Additional Manufacturer Narrative
Additional information d9.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The customer reported that upon opening the oasis dual drain, it was noticed that the proximal end of both patient tubes were kinked, just beside the drain connector.The customer believed this would restrict flow through the tubes and did not use the drain.Evaluation of the returned product confirmed that the ends of both patient tubes were kinked and did not return to their form when removed from the packaging.The patient tubes failed to meet their specifications as kinks are not considered acceptable.This complaint is confirmed.The device history record was reviewed, as were the incoming inspection records of the lots of tubes used.No nonconformities or anomalies were identified in any records.A review of cars and capas identified car 411305 related to kinked patient tubing.The investigation for capa request 411305 identified complaints for kinking of the patient line tubing in oasis dual drain models.The samples were returned for assessment by atrium to confirm functionality.Upon review of the returned patient tube sets, there was one kink in the same location on every tubing set evaluated.An assessment was completed and it was determined that root cause of the kinking in the dual chest drain models is the result of the design changes implemented under dcqp dd016636-002.The design changes include decreasing the wall thickness and increasing the height of the tube set pouches.Capa 439435 was initiated to handle the corrective action, which involved increasing the wall thickness of patient lines that had previously been reduced.Actions for capa 439435 were implemented later the same month that the drain for this complaint was manufactured.No complaints for this issue have been received for any drains manufactured after the implementation of that capa.The root-cause of this issue was determined to be a design control issue, which has since been corrected.
Event or Problem Description
N/a.

• Brand Name: OASIS DOUBLE DRAIN
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 13447744
• Report Number: 3011175548-2022-00045
• Device Sequence Number: 12121807
• Product Code: CAC
• UDI-Device Identifier: 00650862112016
• UDI-Public: 00650862112016
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2022

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: 10/07/2024
• Device Model Number: 3620-100
• Device Catalogue Number: 3620-100
• Device Lot Number: 476026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 02/14/2022; 09/21/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 02/15/2022; 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male