THOPAZ+ PUMP SALE
Report
- Report Number
- 1419937-2019-00086
- Event Type
- Death
- Date Received
- June 27, 2019
- Date of Event
- May 14, 2019
- Manufacturer
- MEDELA AG
- Product Code
- BTA
- PMA / PMN Number
- K141553
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
THE THOPAZ+ DEVICE (SN (B)(4)) INVOLVED IN THE INCIDENT, AS WELL AS TWO (2) OTHER THOPAZ+ DEVICES AND THREE (3) DOCKING STATIONS (SN'S (B)(4)) USED IN THE APPLICABLE HOSPITAL, WERE RETURNED TO MEDELA AG FOR INVESTIGATION. THOUGH IT IS NOT KNOWN WHICH DOCKING STATION WAS USED WITH THE DEVICE INVOLVED IN THE INCIDENT (SN (B)(4)), ALL OF THE DOCKING STATIONS WERE ANALYZED. PRODUCTION RECORDS (DHR), AS WELL AS SERVICE RECORDS, RELATIVE TO ALL OF THE RETURNED DEVICES WERE REVIEWED AND NO DEVIATIONS FROM SPECIFICATION WERE IDENTIFIED. IT WAS ALSO NOTED THAT ALL THREE (3) OF THE DEVICES HAD THE MOST RECENT FIRMWARE VERSION 1.01 INSTALLED. THE THOPAZ+ DEVICE (SN (B)(4)) WAS ANALYZED AND THE LOG FILE, WHICH RECORDS A HISTORY OF DEVICE SETTINGS, AS WELL AS MEASURED VACUUM VALUES, COLLECTED FLUID VOLUMES, AIR LEAKAGE RATES, AND CHARGING STATUS (LOADING VS. ON BATTERY), ALL WITH RESPECTIVE DATE/TIME STAMPS, WAS RETRIEVED FROM THE INTERNAL MEMORY. GRAPHS WHICH ARE IN THE ATTACHED PRODUCT EVALUATION SHOW THE THERAPY DETAILS FOR THE DURATION OF THE THERAPY IN FIGURE 1 AND FOR THE MORNING HOURS OF (B)(6) 2019, THE DATE OF THE CARDIAC ARREST, IN FIGURE 2. OVER THE COURSE OF THE THERAPY, THIRTY-FIVE (35) "SYSTEM CLOGGED" ALARMS WERE TRIGGERED, ALL OF THEM CLEARED WITHIN SECONDS AFTER THEY OCCURRED, EXCEPT FOR TWO (2), WHICH WERE CLEARED AFTER A FEW MINUTES. DESPITE THE ALARMS, THE VACUUM LEVEL REMAINED AT THE SET VALUES THROUGHOUT THE THERAPY. TABLE 1 IN THE ATTACHED PRODUCT EVALUATION SUMMARIZES THE EVENTS RECORDED IN THE LOG FILE FROM 3:50 (ALL TIMES HEREIN ARE UK LOCAL TIME) ON (B)(6) 2019, THE DATE OF THE CARDIAC ARREST. IRRELEVANT DATA WAS REMOVED FROM THE TABLE FOR READABILITY; HOWEVER, THE ORIGINAL AND FULL DATA SET IS AVAILABLE. THE DATA INDICATES THAT AT 3:59, THE BATTERY WAS "ALMOST FULL" (ALMOST COMPLETELY CHARGED) AND THE DEVICE WAS DISCONNECTED FROM ITS EXTERNAL POWER SUPPLY. "BATTERY LOW WARNING" ALARMS WERE TRIGGERED SIX (6) TIMES BETWEEN 6:17 AND 6:52, BEFORE THE PUMP RAN OUT OF BATTERY AT 7:16 AND SHUT OFF. THE DEVICE WAS RECONNECTED TO AN EXTERNAL POWER SUPPLY AT 8:46 AND THE DEVICE WAS RESTARTED AT 9:10. WHILE THE DEVICE WAS RUNNING, IT CREATED THE SET VACUUM LEVEL. ALSO, BETWEEN 6:20 AND 6:48, THREE (3) "FILTER CLOGGED" ALARMS WERE TRIGGERED, AND THE AGGREGATE SHUT OFF AS A RESULT. THIS IS ACCORDING TO THE DESIGN SPECIFICATIONS AND DESCRIBED IN THE INSTRUCTIONS FOR USE ON PAGES 43-44. AS THE FLUID LEVEL IN THE 800ML CANISTER WAS ONLY 543ML AT THE TIME, IT CAN BE ASSUMED THAT MOVEMENT OF THE DEVICE AND/OR CANISTER RESULTED IN FLUID GETTING IN CONTACT WITH THE FILTER AND CLOGGED THE FILTER. SEVERAL MANIPULATIONS OF THE CANISTER DID NOT RESOLVE THE "FILTER CLOGGED" ALARMS AND AT 6:50 A NEW CANISTER WAS CONNECTED AND THE DEVICE RESTARTED, WHICH RESOLVED THE "FILTER CLOGGED" ALARM. HOWEVER, BETWEEN THE 6:20 AND 6:50, THERE WAS NO VACUUM GENERATED AS THE PUMP WAS NOT RUNNING. ACCORDING TO THE DATA IN THE LOG FILE, IT CAN BE CONCLUDED THAT THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS AND PER ITS INTENDED USE BEFORE, DURING AND AFTER THE TIME OF THE REPORTED CARDIAC ARREST. THE VACUUM LEVEL WAS AS SET BY THE USER. COLLECTED FLUID VOLUMES AND AIR LEAKAGES WERE CONTINUOUSLY RECORDED AND WERE DETERMINED TO BE WITHIN THE RANGE OF THE DEVICE'S CAPABILITIES. IT CAN, THEREFORE, BE CONCLUDED THAT THE CARDIAC ARREST WAS NOT CAUSED BY A MALFUNCTION OF THE DEVICE. THE BATTERY CHARGING ISSUES REPORTED BY THE USER WERE ALSO INVESTIGATED BY ANALYZING THE RETURNED DOCKING STATIONS, WHICH ARE USED TO CHARGE THE THOPAZ DEVICE. NO CHARGING ISSUE COULD BE IDENTIFIED RELATED TO DOCKING STATION 1637557 AND IT FUNCTIONED AS INTENDED DURING TESTING. DURING FUNCTIONAL TESTING OF DOCKING STATIONS 1637563 AND 1633736, INTERMITTENT CONTACT PROBLEMS WERE IDENTIFIED BETWEEN THE DOCKING STATION AND THE VARIOUS DEVICES CONNECTED THERETO. DRIED RESIDUE FROM FLUID INGRESS AND CONTAMINATION INSIDE THE DOCKING STATION AND ON CHARGING CONTACTS GENERATED A REDUCED CONTACT SITUATION, WHICH RESULTED IN INTERMITTENT ISSUES CHARGING THE DEVICES, EVEN IF THE DEVICES WERE CORRECTLY POSITIONED ON THE DOCKING STATION, AND THE BATTERY WAS LEFT NOT BEING LOADED FOR VARIOUS PERIODS OF TIME. REFER TO FIGURES 3-7 IN THE ATTACHED PRODUCT EVALUATION FOR EVIDENCE OF THE CONTAMINATION. THE CONTAMINATION IDENTIFIED ON AND INSIDE THE DOCKING STATION IS A CLEAR INDICATION THAT ON ONE OR SEVERAL OCCASIONS, LIQUID WAS SPILLED ONTO THE DOCKING STATION AND IS NOT INDICATIVE OF A PRODUCT MALFUNCTION. ADDITIONALLY, NO CHARGING ISSUES WERE DETECTED WHEN THE DEVICE WAS CHARGED WITH A POWER SUPPLY, RATHER THAN A DOCKING STATION. PER PAGE 12 OF THE THOPAZ+ INSTRUCTIONS FOR USE, "APPROXIMATELY 30 MINUTES BEFORE THE BATTERY IS FULLY EMPTY, AN ACOUSTIC SIGNAL SOUNDS AND THE BATTERY SYMBOL STARTS TO BLINK. THE ACOUSTIC SIGNAL CAN BE MUTED, BUT THE BATTERY SYMBOL CONTINUES TO BLINK UNTIL THE BATTERY IS EMPTY. THE SET PRESSURE IS MAINTAINED, BUT THE BATTERY SHOULD BE RECHARGED AS SOON AS POSSIBLE." AND "THE BATTERY SYMBOL WILL BLINK WITH AN ACOUSTICAL SOUND FOR 10 MINUTES PRIOR TO THE BATTERY FULLY DISCHARGING, UNLESS THE PUMP IS SWITCHED OFF EARLIER. THE ACOUSTIC SOUND CANNOT BE MUTED DURING THIS 10 MINUTES. IF THE THOPAZ+ IS NOT CONNECTED TO A POWER SOURCE, THE PUMP WILL SWITCH OFF AUTOMATICALLY AFTER 10 MINUTES. THE NEGATIVE PRESSURE IS NOT MAINTAINED AFTER THE PUMP TURNS OFF." THE EVIDENCE IN THE DEVICE'S LOG FILE INDICATES THAT THE DEVICE GENERATED SEVERAL REPEAT VISUAL AND AUDIBLE "BATTERY LOW" WARNINGS AND A FINAL "BATTERY EMPTY" ALARM BEFORE THE DEVICE SHUT OFF DUE TO AN EMPTY BATTERY (7:16). THIS SHUT-OFF OCCURRED MORE THAN ONE HOUR AFTER THE REPORTED CARDIAC ARREST (6:10) AND CAN BE EXCLUDED AS A CAUSE OF THE CARDIAC ARREST. AS AN ALTERNATIVE TO CHARGING THE BATTERY USING THE DOCKING STATION, DIRECT CHARGING OF THE BATTERY OVER THE DEVICE'S LOADING SOCKET IS ALSO A POSSIBILITY AT ANY TIME. (B)(4).
ON 05/22/2019, THE CUSTOMER ALLEGED TO MEDELA UNITED KINGDOM THAT A PATIENT, WHO WAS PLACED ON A THOPAZ+ CHEST DRAINAGE DEVICE ON (B)(6) 2019 FOLLOWING A LEFT LUNG RESECTION, WENT INTO CARDIAC ARREST IN THE EARLY MORNING HOURS OF (B)(6) 2019 AND EXPIRED ON (B)(6) 2019. THE CUSTOMER INDICATED THAT AFTER PLACEMENT ON THE DEVICE FOLLOWING THE RESECTION PROCEDURE, THE PATIENT'S AIR LEAK WAS GRADUALLY IMPROVING AND THAT IN THE EVENING OF (B)(6) 2019, THE AIR LEAK WAS AT APPROXIMATELY 500 ML/MIN. IN THE MORNING OF (B)(6) 2019, AFTER THE CARDIAC ARREST, THE CUSTOMER CONDUCTED AN ANALYSIS OF DATA AND GRAPHS OBTAINED FROM THE DEVICE AND INDICATED THAT IT APPEARED THAT ON (B)(6) 2019, WHEN THE PATIENT WAS IN THE ADVANCED INTENSIVE CARE UNIT, THE DEVICE RAN OUT OF BATTERY POWER AND A CLOT CLOGGED THE SYSTEM, PRODUCING A BLOCKAGE WHICH MAY HAVE RESULTED IN THE BUILD-UP OF AIR IN THE CHEST CAVITY, TRIGGERING A TENSION PNEUMOTHORAX AND EVENTUAL CARDIAC ARREST.
THE LOG FILE FROM THE DEVICE WAS RECEIVED FROM THE CUSTOMER BY THE MANUFACTURER AND THE FOLLOWING IS A SUMMARY REGARDING THE DATA FROM (B)(6) 2019: BETWEEN 12:22 AM AND 4:51 AM, THERE WERE FIVE (5) CLOGGED TUBING ALARMS, FOUR (4) OF WHICH WERE PROMPTLY CONFIRMED BY THE CUSTOMER BETWEEN 7:17 AM AND 7:52 AM THERE WERE SEVEN (7) LOW BATTERY WARNINGS, IN ADDITION TO THE FOLLOWING: AT 7:20 AM THERE WAS ONE (1) FILTER CLOGGED ALARM. AT 7:47 AM THE DEVICE LOGGED AS IN OPERATION AND THERE WAS ONE (1) WARNING REGARDING UNRECOGNIZED CANISTER, ONE (1) FILTERED CLOGGED ALARM, WHICH WAS IMMEDIATELY RESOLVED, AND ONE (1) ALARM FOR FAILING THE SELF-TEST. AT 7:48 AM THERE WAS ONE (1) FILTER CLOGGED ALARM, WHICH WAS RESOLVED AT 7:49 AM. AT 7:50 AM, THE CANISTER WAS CHANGED AND AT THAT TIME, THE DEVICE LOGGED AS IN OPERATION. AT 8:16 AM, THERE WAS A BATTERY EMPTY ALARM. AT 10:09 AM, THERE WAS A WARNING THAT THE DEVICE WAS IN STANDBY MODE FOR MORE THAN 5 MINUTES. AT 10:10 AM, THE DEVICE LOGGED AS IN OPERATION. AT 10:23 AM, THERE WAS ONE (1) LOW BATTERY WARNING, WHICH THE DEVICE LOGGED AS RESOLVED AT 11:03 AM. AT 11:03 AM, THE DEVICE WAS PUT INTO STANDBY MODE. AT 11:03 AM, THE DEVICE LOGGED AS IN OPERATION. AT 11:05 AM, THE PRESSURE WAS CHANGED TO 2 KILOPASCALS. AT 11:33 AM, THE DEVICE WAS PUT INTO STANDBY MODE. AT 11:34 AM, THE DEVICE LOGGED AS IN OPERATION. AT 11:34 AM, THE DEVICE WAS PUT INTO STANDBY MODE. AT 11:39 AM, THERE WAS A WARNING THAT THE DEVICE WAS IN STANDBY MODE FOR MORE THAN 5 MINUTES. AT 11:41 AM, THE STANDBY WARNING WAS RESOLVED. BECAUSE THIS INFORMATION IS NOT CONDUCIVE TO FORMING A CONCRETE CONCLUSION, ANALYSIS OF THE DEVICE AND DOCKING STATIONS RETURNED BY THE CUSTOMER IS IN PROCESS.
ON (B)(4) 2019, THE CUSTOMER ALLEGED TO MEDELA (B)(6) THAT A PATIENT, WHO WAS PLACED ON A THOPAZ+ CHEST DRAINAGE DEVICE ON (B)(6) 2019 FOLLOWING A LEFT LUNG RESECTION, WENT INTO CARDIAC ARREST IN THE EARLY MORNING HOURS OF (B)(6) 2019 AND EXPIRED ON A DATE WHICH IS CURRENTLY UNKNOWN. THE CUSTOMER INDICATED THAT AFTER PLACEMENT ON THE DEVICE FOLLOWING THE RESECTION PROCEDURE, THE PATIENT'S AIR LEAK WAS GRADUALLY IMPROVING AND THAT IN THE EVENING OF (B)(6) 2019, THE AIR LEAK WAS AT APPROXIMATELY 500 ML/MIN. IN THE MORNING OF (B)(6) 2019, AFTER THE CARDIAC ARREST, THE CUSTOMER CONDUCTED AN ANALYSIS OF DATA AND GRAPHS OBTAINED FROM THE DEVICE AND INDICATED THAT IT APPEARED THAT ON (B)(6) 2019, WHEN THE PATIENT WAS IN THE ADVANCED INTENSIVE CARE UNIT, THE DEVICE RAN OUT OF BATTERY POWER AND A CLOT CLOGGED THE SYSTEM, PRODUCING A BLOCKAGE WHICH MAY HAVE RESULTED IN THE BUILD-UP OF AIR IN THE CHEST CAVITY, TRIGGERING A TENSION PNEUMOTHORAX AND EVENTUAL CARDIAC ARREST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535163 | THOPAZ+ PUMP SALE | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) | BTA | MEDELA AG | 0791000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death |