MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PRESSURE MONITORING CABLE

Model Number 896507021

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2016

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for analysis; however, it has not been received yet.Upon return of the product for evaluation a supplemental report will be submitted with the evaluation findings.

Event Description

It was reported that the there was a discrepancy in blood pressure values.The patient had a femoral line in with balloon pump and the pressure was reading 70/40mmhg.They placed an arterial line in the radial artery and the pressure read 140/80mmhg.The clinician noted that there was a period of about 45 minutes where the patient had no urine output, due to the clinician's belief that the radial line was correct.The clinician re-zeroed the radial arterial line and the values correlated.After about 30 minutes the radial arterial line started increasing.The line was re-zeroed again.The dpt line was replaced and the issue persisted.The cable was replaced and the issue was resolved.Procedure: cabg & vsd repair.Post surgery the patient was in icu, intubated and slowly improving.

Manufacturer Narrative

One marquette cable was returned for product evaluation.A visual inspection was performed on the cable and there was no physical damage that was observed.The continuity test was performed on the 5 conductors and there were no open or short wire connections that were found.A simulation was performed using a known good working ge dash 3000 patient monitor and there were no issues that were displayed.The monitor pressure zeroed successfully.There were four simulated pressure values that were applied and the patient monitor displayed accordingly with no increased pressure reading as reported.There was no defect found.The device service history record review could not be completed as the serial/lot number is unknown.The reported event was not confirmed by evaluation.There are no indications or evidence that a manufacturing defect is responsible for the reported issue.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.It could not be determined if any clinical or procedural factors may have contributed to the stated event.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.No further actions will be taken at this time.

• Brand Name: PRESSURE MONITORING CABLE
• Type of Device: PRESSURE MONITORING CABLE
• 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 selawski ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 6169151
• MDR Text Key: 62255702
• Report Number: 2015691-2016-03674
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2016

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
• Device Operator: Health Professional
• Device Model Number: 896507021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BALLOON PUMP, DISPOSABLE PRESSURE TRANSDUCER
• Patient Weight: 95