8010762-2019-00043
Report
- Report Number
- 8010762-2019-00043
- Event Type
- Malfunction
- Date Received
- February 25, 2019
- Date of Event
- February 11, 2019
- Report Date
- February 25, 2019
- PMA / PMN Number
- K102726
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
(B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). REFERENCE EXEMPTION # E2018002. THE E-DRIVE WAS SENT TO REPAIR DEPOT IN (B)(4). WORK PERFORMED ON 2019-02-19. RESULTS OF SERVICE ORDER REPORT (B)(4): "E-DRIVE REPAIR. BOTTOM GEAR WAS PROPERLY INSTALLED TO ALLOW HAND CRANK TO TURN IN A CLOCKWISE DIRECTION TO ENGAGE PROPER FLOW. PERFORMED FULL FUNCTIONAL TEST AS PER SERVICE MANUAL. ALL TESTS PASSED. NOTE: REFERENCE TRACKWISE COMPLAINT # (B)(4)" E-DRIVE HAND CRANK TURNING COUNTER-CLOCKWISE" REPAIRED SEE ABOVE DESCRIPTION." THE ROOT CAUSE IS A HUMAN ERROR DURING SERVICE/ MAINTENANCE. THUS THE FAILURE COULD BE CONFIRMED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME. AS A CORRECTIVE ACTION AN NON-CONFORMANCE-PROCESS (NC) WAS INITIATED: (B)(4).
(B)(4). IT WAS DISCOVERED THAT THE E-DRIVE IS TURNING ANTICLOCKWISE. THE FACTORY HAS CHECKED ON THIS AND TURNING THE HAND CRANK COUNTERCLOCKWISE ACTUALLY WILL DAMAGE THE BLOOD CELLS. THE CORRECT DIRECTION OF THE HAND CRANK IS CLOCKWISE WHERE YOU WOULD FEEL SOME RESISTANCE. THAT IS WHEN THAT 1 GEAR IS INSTALLED CORRECTLY AND THEN TURNING THE HAND CRANK COUNTER-CLOCKWISE THERE ISN¿T RESISTANCE AND IT IS FREE SPINNING.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |