MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000 PUMP UNIT; EVPMP

Model Number	EVPMP
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned for evaluation.When the product evaluation has been completed, a supplemental report will be submitted.The device history record review was completed and all inspections passed with no non-comformances.
Event or Problem Description
The pump unit failed functional test for pressure at various flows with the difference pressure outlet ad at 150 normal liters per hour.The measurement is 136.3 mmhg and the limits are from plus or minus 10 mmhg.The test technician found that the pumps manifold bottom had cracks around the pems for the manifold lid.All tests passed after the manifold bottom was replaced.There were no error messages or alarms that displayed.There was no patient involvement.
Additional Manufacturer Narrative
New information was received that the test technician reported the incorrect information for section v whether erroneous hemodynamic or pressure values were observed regarding the in process failure of the evpmp during lab testing.There were no erroneous values noted and this was due to it getting the failing values from test equipment when not connected to an ev1000 monitor.This requires a correction of mdr reportability to not reportable because although the pump unit failed testing there were no erroneous values reported.

• Brand Name: EV1000 PUMP UNIT
• Common Device Name: EVPMP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 12579949
• Report Number: 2015691-2021-05526
• Device Sequence Number: 17016062
• Product Code: DXN
• UDI-Device Identifier: 00690103193213
• UDI-Public: 0100690103193213
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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 Expiration Date: 05/24/2023
• Device Model Number: EVPMP
• Device Catalogue Number: EVPMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown