MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT PUMP UNIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number EVPMP

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

The device history record was reviewed and it supports that there were no non-conformances noted for any reason. The device is expected to be evaluated; however, at the time of this report, the device has not been returned. A supplemental report will be submitted to communicate the results of the complaint investigation results. The pc2k (pressure controller) will also be submitted and the mdr number will be referenced in the follow up for the pump unit.

Event Description

It was reported, that during the first day of use, of an ev1000 pump unit the clearsight measurements were 110-120/80-90 while the nibp (non-invasive blood pressure) were 150/65. On the second day of use the clearsight measurement were 93/56 compared to the nibp of 126/56. The hrs was replaced but the problem persisted. The patient was not treated based on the inaccurate clearsight values. No patient compromise was reported. Two devices were implicated in this event; one for the ev1000 pump unit and one for the ev1000 pressure controller.

Manufacturer Narrative

The device history record review was completed and all manufacturing inspections passed with no non-conformances. Examination of the returned device was unable to replicate the customer¿s complaint. Evaluation testing supports that the device performs as expected. It is unknown whether procedural processes or a specific circumstance played a role in the customer¿s experience, as the fault could not be replicated and no other issues were detected. No further actions are required at this time. Edwards will continue to review and monitor all events. If action is required, an appropriate investigation will be performed. The pressure controller (pc2k) was also submitted and the mdr number is 2015691-2016-02234.

• Brand Name: CLEARSIGHT PUMP UNIT
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5796818
• MDR Text Key: 49634823
• Report Number: 2015691-2016-02233
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: EVPMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse