MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION METRIQ PUMP

Model Number	86456
Medical Device Problem Codes	Defective Device (2588); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis in good condition with no visible damage observed.The generator and cable generator to pump was not returned with the unit for evaluation.The unit passed functional testing.Stand by flow increased the flow up to 5 to continue to flow was not observed during the test.Stand by flow increase 1 by 1 manually only by user.
Event or Problem Description
It was reported that the pump got stuck on standby flow mode.During an ablation procedure, the metriq pump continually got stuck during the stand by flow.They manually increased the flow up to 5 ml/min to continue to flow.The procedure was completed with the original device.No serious injury or adverse patient effects occurred.
Event or Problem Description
It was reported that the pump got stuck on standby flow mode.During an ablation procedure, the metriq pump continually got stuck during the stand by flow.They manually increased the flow up to 5 ml/min to continue to flow.The procedure was completed with the original device.No serious injury or adverse patient effects occurred.It was further reported that the error said "pump speed error".
Additional Manufacturer Narrative
The product was returned for analysis in good condition with no visible damage observed.The generator and cable generator to pump was not returned with the unit for evaluation.The unit passed functional testing.Stand by flow increased the flow up to 5 to continue to flow was not observed during the test.Stand by flow increase 1 by 1 manually only by user.

• Brand Name: METRIQ PUMP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8455531
• Report Number: 2134265-2019-03066
• Device Sequence Number: 3014135
• Product Code: OAD
• UDI-Device Identifier: 08714729862260
• UDI-Public: 08714729862260
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: MP0475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/09/2019
• Patient Sequence Number: 1