MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION METRIQ PUMP

Model Number	86456
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was abandoned due to a device malfunction.Prior to an ablation procedure, when preparing the metriq tubing set, the pump was not able to perform the calibration process when closing the cover.The pump was switched off and on, the cover was fully opened and closed again and calibration was tried several more times, but the issue did not resolve.The procedure was canceled, and had to be rescheduled.There were no serious injuries or adverse patient effects.
Event or Problem Description
It was reported that the procedure was abandoned due to a device malfunction.Prior to an ablation procedure, when preparing the metriq tubing set, the pump was not able to perform the calibration process when closing the cover.The pump was switched off and on, the cover was fully opened and closed again and calibration was tried several more times, but the issue did not resolve.The procedure was canceled, and had to be rescheduled.There were no serious injuries or adverse patient effects.
Additional Manufacturer Narrative
The device was returned for analysis.The product was received in fair condition with no visible damage observed.The display powered up, and the green led was lit.The display stated "init self test passed." the display was clearly readable and looked displayed correctly.The pump did not start without the tubing set installed."tubing not loaded" failed to display and automatically clear, and "cover open" displayed instead.During trouble shooting of the unit, it was discovered that the door assembly malfunctioned, and replacing it solved the issue."purge not allowed" failed to display and clear itself in approximately five seconds.Installed tubing set and closed the door.Pump displayed "calibration in progress.".

• Brand Name: METRIQ PUMP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9321138
• Report Number: 2134265-2019-13827
• Device Sequence Number: 419068
• Product Code: OAD
• UDI-Device Identifier: 08714729862260
• UDI-Public: 08714729862260
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P150005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 86456
• Device Catalogue Number: 86456
• Device Lot Number: MP0576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/17/2019
• Patient Sequence Number: 1