OCEAN 2002-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00650862100105), received between Sep 10, 2018 and Sep 6, 2022 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Filling Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

22 other recalls cover devices cleared under the same FDA submission (K043582); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 18, 2023Open, Classified

   Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains

   Z-0316-2024 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2022Fracture; Fracture

  WHEN THE PATIENT GOT OUT OF BED AND MOVED AROUND AFTER THE OPERATION, THE CONNECT SITE BETWEEN THE CHEST DRAINAGE AND THE TISSUE CRACKED. THEN THE DOCTOR CHANGED ANOTHER ONE INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362165 ↗
• MalfunctionApr 12, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  REPORT RECEIVED STATED THAT DURING AN INSPECTION OF AN OASIS DRAIN IN THE WAREHOUSE IT WAS OBSERVED THAT THE TYVEK POUCH ON THE DRAIN HAD A HOLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14089783 ↗
• MalfunctionFeb 2, 2021Tear, Rip or Hole in Device Packaging

  N/A.

  Patient problems: No Patient Involvement

  MAUDE report 11269317 ↗
• MalfunctionDec 6, 2019Break

  N/A.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9432731 ↗
• MalfunctionJul 30, 2019Detachment of Device or Device Component

  NURSE FOUND THAT THE PATIENT TUBE OF THE CHEST DRAIN WAS DETACHED FROM THE CHEST DRAIN UNIT DURING USE, NO BUBBLE WAS FOUND IN SUCTION CONTROL CHAMBER THOUGH IT IS ON SUCTION DRAINAGE. NURSE THEN CHANGED TO ANOTHER CHEST DRAIN IMMEDIATELY, X-RAY CHECK UP WAS DONE AND THE PATIENT WAS FINE.

  Patient problems: No Information

  MAUDE report 8842067 ↗
• MalfunctionJun 7, 2019Component Missing

  N/A

  Patient problems: No Patient Involvement

  MAUDE report 8681121 ↗
• InjuryMar 5, 2019Filling Problem

  REPORT RECEIVED STATED THAT THE DRAINAGE IS UNABLE TO REACH THE 200ML GRADUATION MARK ON THE DRAIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8393088 ↗
• MalfunctionMar 5, 2019Filling Problem

  REPORT RECEIVED STATED THAT THE DRAINAGE IS UNABLE TO REACH THE 200ML GRADUATION MARK ON THE DRAIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8393064 ↗
• InjuryMar 5, 2019Filling Problem

  REPORT RECEIVED STATED THAT THE DRAINAGE IS UNABLE TO REACH THE 200ML GRADUATION MARK ON THE DRAIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8393060 ↗
• MalfunctionSep 10, 2018Tear, Rip or Hole in Device Packaging

  REPORT RECEIVED STATED THAT A SMALL HOLE WAS NOTICED IN THE PACKAGING OF THE DRAIN.

  Patient problems: No Information

  MAUDE report 7862738 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043582. One submission often covers many models, so check the product and lot details in each record.

• Z-0486-2024 · Sep 5, 2023 · Open, Classified
  Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
• Z-0235-2023 · Oct 18, 2022 · Open, Classified
  Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
• Z-1607-2022 · May 25, 2022 · Open, Classified
  GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000
• Z-0307-2022 · Oct 22, 2021 · Open, Classified
  The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber us
• Z-1205-2017 · Dec 23, 2016 · Terminated
  Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establ
• Z-1210-2017 · Dec 23, 2016 · Terminated
  Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lun
• Z-1206-2017 · Dec 23, 2016 · Terminated
  Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-estab
• Z-1209-2017 · Dec 23, 2016 · Terminated
  Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish
• Z-1937-2015 · May 7, 2015 · Terminated
  Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
• Z-1938-2015 · May 7, 2015 · Terminated
  EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
• Z-1935-2015 · May 7, 2015 · Terminated
  Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
• Z-1936-2015 · May 7, 2015 · Terminated
  Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
• Z-1959-2014 · Apr 28, 2014 · Terminated
  Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
• Z-0742-2014 · Nov 19, 2013 · Terminated
  Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.
• Z-0735-2014 · Nov 19, 2013 · Terminated
  Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from th

…and 7 more.