MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PXVPL2284; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number DPTUNKNOWN

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.Lot number was not provided, therefore review of the manufacturing records could not be completed.An in servicing team was sent to the hospital to investigate the reported event.The team observed that the hospital staff were drawing blood back in the vamp (faster than 1cc/sec), leaving the lass value open to air with a syringe attached, breaking the line to add a rose catheter, using incorrect priming technique, power flushing through the lass valve or from the vamp, lass stopcocks in priming position instead of pressure monitoring position, addition of extra tubing (beyond 96 inches), and the bag was not pressurized to 300mmhg.Any of these issues or a combination there of could be a contributing cause of inaccurate pressure readings and/or underdamped waveform.Clinicians were in-serviced on proper use of the dpt system.When observing actual troubleshooting when the arterial line was still in place, improvement of waveform was noted.Additional training and audit of practices will continue until the hospital is fully functional when using disposable pressure transducers.In addition, a troubleshooting guide is in process for additional training.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 this monthly review.

Event Description

It was reported that underdamped waveforms were noted during use of a disposable pressure transducer.The readings observed were 30-40 mmhg higher on the systolic blood pressure (sbp) than expected.A rose filter was added, and the blood pressures started to correlate with expected values.No patient complications were reported.The device is available for examination.Patient demographics were unable to be obtained.

Manufacturer Narrative

As received, with this dpt vamp plus kit, multiple air bubbles were visible inside of the iv set.Blood was visible inside of the pressure tubing near the distal tubing connector.The reported event of pressure reading issue was not confirmed.The returned kit was primed and flushed (with an attached non-edwards filter and iv catheter) without any indication of occlusion or flow restriction.Air bubbles in the iv line were also able to be completely removed from the kit during flushing.The dpt zeroed and sensed pressure accurately on a pressure monitor (without attached iv catheter).No error message was noticed from the monitor.The pressure reading was stable during 8 hours output drift test.Electrical testing also showed that the dpt electronic components were intact because both input and output impedances were within specifications.Zero-offset also met specification.No visible damage was observed from the dpt kit.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: PXVPL2284
• 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: 9110937
• MDR Text Key: 196932930
• Report Number: 2015691-2019-03550
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2019

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: DPTUNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 09/26/2019; 07/23/2020
• Supplement Dates FDA Received: 10/16/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1