OASIS
Report
- Report Number
- 3011175548-2025-000001
- Event Type
- Malfunction
- Date Received
- February 3, 2025
- Date of Event
- January 17, 2025
- Report Date
- April 11, 2025
- Manufacturer
- ATRIUM MEDICAL CORPORATION
- Product Code
- KDQ
- UDI-DI
- 00650862110012
- PMA / PMN Number
- K043140
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW UP REPORT WILL BE SUBMITTED. DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 EVENT SITE NAME: (B)(6).
COMPLAINTS ASSOCIATED WITH DEVICE LEAKS DURING USE RELATED TO AIR LEAK OBSERVED IN THE DETECTION CHAMBER, OR A FLUID LEAK FROM DRAIN OR BETWEEN CHAMBERS OF DRAIN. THE FAILURE MODE HAS NOT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY IN THE PAST TWO YEARS AND HAS A REMOTE PROBABILITY OF RESULTING IN A DEATH OR SERIOUS INJURY, AS DOCUMENTED WITHIN THE RISK MANAGEMENT FILE. ADDITIONALLY, THE FAILURE MODE HAS BEEN CONFIRMED THROUGH THE MEDICAL AFFAIRS TEAM TO BE UNLIKELY TO RESULT IN A DEATH OR SERIOUS INJURY. ATRIUM MEDICAL CORPORATION WILL NO LONGER REPORT FUTURE EVENTS FOR COMPLAINTS ASSOCIATED WITH DEVICE LEAKS DURING USE RELATED TO AIR LEAK OBSERVED IN THE DETECTION CHAMBER, OR A FLUID LEAK FROM DRAIN OR BETWEEN CHAMBERS OF DRAIN, UNLESS THE FAILURE MODE IS FOUND TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.
ADDITIONAL INFORMATION SECTION. RELATED MDR: 3011175548-2025-0000011, 3011175548-2025-0000012. THE USER REPORTED THAT AN OASIS DRAIN LEAKED WHILE IN USE ON A PATIENT. THEY THEN TESTED TWO MORE DRAINS FROM THE SAME LOT WITHOUT ATTACHING THEM TO THE PATIENT AND THEY BOTH LEAKED AS WELL. ALL THREE COMPLAINTS ARE FOR OASIS DRAINS (P/N 3600-100, L/N 509742). THE REPORT STATED THEY WERE LEAKING FROM THE LOWER LEFT EDGE (IT IS ASSUMED THIS IS MEANT FACING THE BACK OF THE DRAIN, AS THE PROVIDED PICTURES ALL SHOW DAMAGE AND LEAKING AT THE LOWER RIGHT CORNER, UNDER THE PATIENT LINE NOZZLE). PICTURES WERE PROVIDED WHICH ALL FOCUS ON THE BOTTOM CORNER UNDER THE PATIENT LINE NOZZLE. ALL THREE DRAINS APPEAR TO BE LEAKING CLEAR FLUID. THE CUSTOMER STATED THAT THE FIRST DRAIN BEGAN LEAKING WHILE IN USE ON A PATIENT. HOWEVER IT DOES NOT APPEAR TO BE PLEURAL FLUID LEAKING OUT. THE FLUID LEAKING OUT IS CLEAR. THE USER DESCRIBES CORRECTLY FILLING THE WATER SEAL THROUGH THE BLUE SUCTION NOZZLE, WHICH SHOULD FILL THE WATER SEAL AND TURN BLUE WHEN IT CONTACTS THE BLUE DYE BALL. THE PICTURE SHOWING THE PLEURAL FLUID DOES NOT SHOW THE WATER SEAL CHAMBER SO IT CANNOT BE CONFIRMED VISUALLY IF IT WAS FILLED CORRECTLY. THE ONLY PICTURE RECEIVED THAT SHOWS THE WATER SEAL CHAMBER IS FOR ONE OF THE DRAINS THAT WAS TESTED WITHOUT A PATIENT, AND THAT ONE DOES NOT APPEAR TO HAVE FLUID IN THE WATER SEAL CHAMBER. THAT PICTURE SHOWS LEAKED FLUID AT THE LOWER RIGHT CORNER AND THERE IS RESIDUAL WATER LEFT IN THE PATIENT LINE. THE USER ALSO PROVIDED PICTURES OF THE DRAINS' PACKAGING WHICH IS DENTED IN THE LOWER CORNER, CONSISTENT WITH THE LOCATION OF THE LEAKS. PICTURES OF THE DRAINS SHOW WHITE STRESS MARKS IN THAT SAME LOWER RIGHT CORNER. THE DAMAGE TO THE DRAINS AND PACKAGING IS CONSISTENT WITH AN IMPACT SUCH AS THE SHIPPING BOX BEING DROPPED ON A LOWER EDGE. A DHR REVIEW WAS COMPLETED AND NO ANOMALIES IN MANUFACTURING WERE IDENTIFIED. THE PACKAGING DAMAGE SEEN IN THE PICTURES INDICATES THIS MOST LIKELY OCCURRED AFTER MANUFACTURING WHEN THE DRAINS WERE PACKAGED TOGETHER. THE IFU PROVIDES ADEQUATE INSTRUCTIONS FOR THE SETUP AND USE OF THE DEVICE. THE IFU INSTRUCTS THE USER NOT TO USE THE DEVICE IF IT OR THE PACKAGING IS DAMAGED. THE HAZARDOUS SITUATION/HARM IS ADDRESSED IN THE HARM HAZARDS ANALYSIS DOCUMENT WHICH ASSIGNS IT A SEVERITY LEVEL OF 1. THIS WAS DETERMINED TO BE APPROPRIATE BASED ON THE HARM THAT WAS REPORTED IN THE COMPLAINT. COMPLAINT TRENDING CONCLUDED THAT THE ACTUAL OCCURRENCE LEVEL DID NOT EXCEED THE ANTICIPATED OCCURRENCE LEVEL. NO EXCURSIONS WERE IDENTIFIED. THIS INVESTIGATION CONFIRMED THE DEVICE NONCONFORMANCES AND REQUIRES ESCALATION, HOWEVER CORRECTIVE ACTION REQUEST (1242757) IS ALREADY OPENED FOR THIS ISSUE SO THESE COMPLAINTS WILL BE INCLUDED WITHIN THE INVESTIGATION. THE PROVIDED PICTURES SHOW DAMAGE TO THE PACKAGING AND TO THE LOWER RIGHT CORNER OF THE DRAINS (UNDER THE PATIENT NOZZLES). THE MOST LIKELY CAUSE OF THIS IS AN IMPACT TO THE SHIPPING BOX THAT THE DRAINS WERE PACKAGED IN WHICH DAMAGED THE DRAIN COVER WELD, COMPROMISING THE SEAL OF THE DRAIN. BOTH THE COMPLAINTS AND A DEVICE NONCONFORMANCES ARE CONFIRMED. THE ROOT CAUSE OF THESE COMPLAINTS IS SUPPLY CHAIN - HANDLING DAMAGE.
THE HOSPITAL'S PULMONOLOGY TECHNIQUES DEPARTMENT REPORTED THAT THE CHEST DRAINAGE BOX LEAKS FLUID FROM THE LOWER LEFT EDGE. THREE UNITS FROM THE SAME BATCH WERE TESTED, ALL SHOWING THE SAME DEFECT. THERE WAS NO INJURY TO THE PATIENT.
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Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1160199 | OASIS | BOTTLE, COLLECTION, VACUUM | KDQ | ATRIUM MEDICAL CORPORATION | 3600-100 | 509742 | 00650862110012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | UNKNOWN. |