MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VO0501TSPL01

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

One single dpt-vamp flex kit with iv set and pressure tubing was received for evaluation.The reported event of pressure measurement issue was confirmed.The dpt did not zero nor sense pressure on the pressure monitor.Electrical testing showed that output impedance met specification, but the input impedance was out of specification.Additional a crack was observed on the sensor chip inside the dpt the crack runs across the entire sensor chip and can affect the input circuit.No visible damage was observed at solder joints, dpt cable connector, or at the cable.Additional task has been assigned to manufacturing site for further investigation related to the manufacturing process.A device history record review was completed and documented that device met all specifications upon distribution.Poor dynamic response can be caused by air bubbles, clotting, and excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.The assembly may be tested for dynamic response by observing the pressure waveform on an oscilloscope or monitor.Bedside determination of the dynamic response of the catheter, monitor, kit and transducer system is done after the system is flushed, attached to the patient, zeroed and calibrated.A square-wave test may be performed by pulling the snap tab device and releasing quickly.Pressure readings can change quickly and dramatically because of loss of proper calibration, loose connection, or air in the system.Pressure readings should correlate with the patient¿s clinical manifestations.It is not known if user or procedural factors may have contributed to the stated event.In this event, there was no patient compromise noted.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 a part of the monthly review.

Event Description

It was reported that the arterial blood pressure value was 26mmhg on the first day of use, even though the expected value was around 100mmhg.The patient was not treated based on the incorrect values.The dpt was able to zero before use.The customer flushed and checked the system to trouble shoot the device, but the problem was not solved.Occlusion, leakage or kink was not observed.When the device was replaced, the problem was solved.The error message was not indicated.Philips patient monitor was used.There is no data available.Whether there was a problem with the shape of the pressure waveform or not, and if the value and the waveform matched or not were unknown.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Additional investigation confirmed that there is a crack on the sensor chip from visual examination of the sensor and the x-ray.In one of the pressure tests, the dpt sensor zeroed and sensed pressure accurately on the pressure monitor.Electrical testing showed both input impedance and output impedance were within specifications.On the second pressure test the dpt sensor zeroed and sensed pressure; however the pressure reading was drifting lower.On the third round of pressure test the dpt sensor did not zero nor sense pressure.Electrical testing showed that output impedance met specification, but input impedance was out of specification on second and third rounds of pressure test.Further investigation has been assigned for non-conformances related to the manufacturing.

Manufacturer Narrative

Based on the severity of the nonconformance, the dpt housing - sensor chip cracked can provide an inaccurate values that can lead to inappropriate/ unintended treatment.This condition has been evaluated under pra # (b)(4).Rev.A.  this product is manufactured by our supplier and a notification was made to their personnel about the condition.  the complaint assessment done concluded that the sensor chip cracked's root cause was found during supplier amphenol process.A possible cause of cracks on the sensor chip could be wear on machine components. however, the supplier continuous monitoring of daily fet yield to take action, in case a negative trend is observed.A 100% of all units are verified during the final electrical test and also a sample is performed by edwards to release the manufactured units.There are monthly meetings with the supplier about the process performance as well.Based on this information, supplier was notified of condition and crack defects will continue to be monitored through the complaint system and supplier monthly meetings.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• MDR Report Key: 10029030
• MDR Text Key: 194844493
• Report Number: 2015691-2020-11797
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/14/2020

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 Expiration Date: 11/30/2021
• Device Model Number: VO0501TSPL01
• Device Lot Number: NC1182MT, NC061, OR LU0855MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2020
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 05/06/2020
• Supplement Dates Manufacturer Received: 06/17/2020; 07/07/2020; 07/23/2020
• Supplement Dates FDA Received: 06/26/2020; 07/10/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1