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

Model Number PX260

Device Problems Device Alarm System (1012); False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Zero (1683)

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

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation due to coronavirus situation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.The device history record was reviewed and passed with no non-conformances.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.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 during use in a (b)(6) patient being treated for tumor of the head of the pancreas, the arterial catheter was placed with connection of this disposable pressure transducer (dpt) that after a first zero, the arterial pressures obtained were falsely high (250 mmhg).Furthermore, new attempts to zero were not possible.Additionally, different connectors were changed but the issue remained.The pressure line was changed to solve the issue and a new zero was possible.There were no consequences because of immediately identified defect.There was no allegation of patient injury.As per additional information, it was confirmed the inaccurate value provided and compared to an arm cuff (homo / contralateral arm unknown), was less than 100mmhg, which was the pressure expected according to the patient status.Additionally, during the first zero of the device, the value was outliers but it still displayed a pressure curve.Then the device was rezeroed, but the error message "zero sensor impossible" was displayed, asking to renew a zero.Since a new zero was impossible, the sensor was changed.The device was available for evaluation; however, it was further confirmed that due to coronavirus circumstances, the devices was not available to be sent to the materiovigilance service.

Manufacturer Narrative

One single dpt sensor with iv set was received for evaluation.The reported event of inaccurate values could not be confirmed.The dpt sensor did not zero nor sense pressure on the pressure monitor.Electrical testing showed that both input and output impedances were unstable.Corrosion was observed at contact plates and contact dividers of the dpt cable connector.Corrosion was likely caused by liquid.It was warned by the ifu not to expose electrical connections to fluid contact.Electrical testing (bypassing the connector) showed that both input and output circuits of the dpt sensor were intact.Input impedance and output impedance met specifications if they were measured directly from the contact plates.No other visible damage or abnormality was observed from the entire unit.Additional supplement report will be sent if the investigation assigned for any manufacturing non-conformances is confirmed.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.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: PRESSURE MONITORING SET
• 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: 9930248
• MDR Text Key: 195709519
• Report Number: 2015691-2020-11347
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K142749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2020

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 Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 62538177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 07/21/2020; 07/23/2020
• Supplement Dates FDA Received: 07/22/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 43