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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT PUMP UNIT NON-INVASIVE CLEARSIGHT PUMP UNIT

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EDWARDS LIFESCIENCES CLEARSIGHT PUMP UNIT NON-INVASIVE CLEARSIGHT PUMP UNIT Back to Search Results
Model Number EVPMP
Device Problems Smoking (1585); Sparking (2595)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/07/2019
Event Type  malfunction  
Manufacturer Narrative
The product has been returned for evaluation; however, the results are not yet available. Once the evaluation results are available, a supplemental submission will be sent with the evaluation findings. The device history record review has been completed and all manufacturing inspections passed with no non-conformances. The udi number is (b)(4).
 
Event Description
It was reported that there were sparks and smoke coming from the connection between a clearsight pump unit and power cord. The system was not in use on the patient at the time. It had been disconnected from the patient earlier in the evening. It was left in the patient's room connected to the power outlet. The clinician was alerted to the issue when the smoke detector alarm was heard as he was in the patient room. The clinician disconnected the power cord from the power outlet and the sparks stopped. The patient was moved to another room. The clinician stated that an iv bag was not hanging above or around the equipment. There was no patient or hospital personnel harm or injury.
 
Manufacturer Narrative
One clearsight pump unit was received for product evaluation. The device was evaluated and it was found during an external visual inspection that there was black soot and melted plastic on the power cord plug and the pump unit ac inlet. This is consistent with heat damage. In addition, there is evidence of suspected salt crystals observed at the top left lip of the pump unit ac inlet. The suspected salt crystals were collected and analyzed in the chemical lab. They were identified to be significant amounts of sodium and chloride in the sample. They were also detected in the black soot sample. The observations are consistent with what is typically observed as saline ingress of the inlet. This issue leads to arcing or short-circuiting of the pump unit power supply. The ifu includes a warning that instructs the user ¿do not allow any liquid to come in contact with the power connector. [or] allow any liquid to penetrate connectors or the openings in the case. ¿ the facility will be contacted regarding the ifu warning and the edwards clinical field representative has contacted them regarding the issue. There is no indication that a manufacturing defect contributed to the failure. The reported event was confirmed by evaluation. The root cause is consistent with liquid ingress and customer mishandling. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as part of the monthly review. The device service history record review was completed and all manufacturing inspections passed with no non conformances. The submission number for the power cord is 2015691-2019-02779.
 
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Brand NameCLEARSIGHT PUMP UNIT
Type of DeviceNON-INVASIVE CLEARSIGHT PUMP UNIT
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer Contact
lynn thomas
one edwards way
irvine, CA 92614
9497564386
MDR Report Key8833310
MDR Text Key152759736
Report Number2015691-2019-02777
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/27/2022
Device Model NumberEVPMP
Device Catalogue NumberEVPMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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