XLUNG KIT 230
Report
- Report Number
- 3012172416-2023-00026
- Event Type
- Malfunction
- Date Received
- April 6, 2023
- Date of Event
- March 3, 2023
- Report Date
- April 24, 2023
- Manufacturer
- XENIOS AG
- Product Code
- QJZ
- PMA / PMN Number
- K191407
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
PLANT INVESTIGATION: THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THE DESCRIBED SITUATION IS ADEQUATELY ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU) AND/OR ON THE LABEL. TO REDUCE THE RISK OF THROMBOSIS IN THE VASCULAR SYSTEM, AN ADEQUATE BLOOD FLOW AND APPROPRIATE ANTICOAGULATION ARE RECOMMENDED. IN ADDITION, BEFORE INITIATING EXTRACORPOREAL CIRCULATION, ENSURE THAT THE EXTRACORPOREAL CIRCUIT IS FULLY DEAIRED. IT IS HIGHLY UNLIKELY TO DETECT A FAILURE IN A RETENTION SAMPLE, SINCE THE NOISE OCCURRED AFTER 48 HOURS OF USE. THE PROVIDED VIDEO SUGGESTS THAT THE NOISE MIGHT BE DUE TO THE ROTOR TOUCHING THE INNER HOUSING OF THE PUMP HEAD. THE BEARING OF THE PUMP HEAD ROTOR MIGHT HAVE BEEN DAMAGED DURING APPLICATION, FOR EXAMPLE, DUE TO PUMP HEAD THROMBOSIS OR AIR INTAKE. NO NON-CONFORMITIES WERE OBSERVED DURING THE MANUFACTURING PROCESS. BATCH PRODUCTION RECORDS OF THE DP3 PUMP HEADS WERE ALSO FOUND TO BE CONFORMING. SINCE A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CAUSE FOR THE NOISE DESCRIBED COULD NOT BE CONFIRMED.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
IT WAS REPORTED THAT AN ABNORMAL NOISE WAS HEARD COMING FROM THE PUMP HEAD OF AN XLUNG KIT 230 DURING A PATIENT¿S EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY. THE NOISE DID NOT BEGIN UNTIL AFTER 48 HOURS OF USING THE KIT. THE KIT WAS REPLACED AND THE PATIENT LOST APPROXIMATELY 100 ML OF BLOOD IN THE PROCESS. AFTER ¿FLUSHING¿ THE OXYGENATOR, A VIDEO DEMONSTRATION OF THE PUMP HEAD WAS RECORDED TO EXHIBIT THE ABNORMAL SOUND THAT WAS HEARD WHILE USING THE DEVICE. THERE WERE NO ALARMS FROM THE NOVALUNG CONSOLE, AND NONE WERE EXPECTED. THE PUMP HEAD WAS CONFIRMED TO BE PROPERLY SEATED IN THE PUMP DRIVE, AND NO CLOTS WERE NOTICED IN THE PUMP HEAD. IT WAS ALSO CONFIRMED THAT HEPARIN WAS BEING USED FOR ANTICOAGULATION. THE PATIENT WAS ABLE TO CONTINUE TREATMENT AFTER BEING MOVED TO A DIFFERENT SETUP (KIT AND CONSOLE). THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, INJURIES, OR REQUIRE ANY MEDICAL INTERVENTION DUE TO THE BLOOD LOSS. THE KIT WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED.
IT WAS REPORTED THAT AN ABNORMAL NOISE WAS HEARD COMING FROM THE PUMP HEAD OF AN XLUNG KIT 230 DURING A PATIENT¿S EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY. THE NOISE DID NOT BEGIN UNTIL AFTER 48 HOURS OF USING THE KIT. THE KIT WAS REPLACED AND THE PATIENT LOST APPROXIMATELY 100 ML OF BLOOD IN THE PROCESS. AFTER ¿FLUSHING¿ THE OXYGENATOR, A VIDEO DEMONSTRATION OF THE PUMP HEAD WAS RECORDED TO EXHIBIT THE ABNORMAL SOUND THAT WAS HEARD WHILE USING THE DEVICE. THERE WERE NO ALARMS FROM THE NOVALUNG CONSOLE, AND NONE WERE EXPECTED. THE PUMP HEAD WAS CONFIRMED TO BE PROPERLY SEATED IN THE PUMP DRIVE, AND NO CLOTS WERE NOTICED IN THE PUMP HEAD. IT WAS ALSO CONFIRMED THAT HEPARIN WAS BEING USED FOR ANTICOAGULATION. THE PATIENT WAS ABLE TO CONTINUE TREATMENT AFTER BEING MOVED TO A DIFFERENT SETUP (KIT AND CONSOLE). THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, INJURIES, OR REQUIRE ANY MEDICAL INTERVENTION DUE TO THE BLOOD LOSS. THE KIT WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AS IT WAS REPORTEDLY DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2020862 | XLUNG KIT 230 | EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATORY / CARDIOPULMONARY FAILURE | QJZ | XENIOS AG | 8015949 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | NOVALUNG CONSOLE| NOVALUNG CONSOLE |