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

Model Number DPTUNKNOWN

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2018

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.

Event Description

It was reported that the ¿whole set was full of air¿ while using a pressure monitoring kit on a pediatric patient.The issue was found an hour after the patient entered the picu.The monitor alarmed as the arterial line went flat.After the incident, the line was disconnected from the patient and the set was replaced.The customer indicated that it was unknown how the air was introduced into the set unless it wasn¿t set up properly.The line was set up in the operating room prior to the patient coming to the picu.There was no leakage noted in the system.The pressure bag had 500ml capacity and was nearly full.The nurse who was in immediate contact with the patient stated that air did not enter the patient and there was no allegation of patient injury.The device will be returned for examination.

Manufacturer Narrative

One arterial and one cvp disposable pressure transducer was returned for examination.The reported event of air leakage issue was not confirmed.As received, the dpt was attached to pressure tubing and a cap and all connections were tight and secure.The dpt with attached pressure tubing was primed at a pressure of 45 mmhg and flushed at a pressure of 345 mmhg as instructed by edwards instructions for use.The air bubbles were completely removed from the dpt during the flushing process and no new air bubbles entered the dpt.Leakage was not detected from the dpt with the attached pressure tubing during a leak test.In addition, there was no damaged observed on the dpt.The iv tubing was not returned.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.Lot or serial number was not provided, therefore review of the manufacturing records could not be completed.It is common clinical practice to inspect all products before use.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.The ifu states: ¿do not allow air bubbles to enter the setup, especially when monitoring arterial pressures.¿ ¿if all air is not removed from the bag, air may be forced into the patient¿s vascular system when the solution is exhausted.¿ ¿significant distortion of the pressure waveform or air emboli can result from air bubbles in the setup.¿ ¿periodically check fluid path for air bubbles.Ensure that connecting lines and stopcocks remain tightly fitted.¿ air emboli is a stated complication in the ifu.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.It is unknown whether user or procedural factors played a role in this event.There was no patient harm noted from this 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 this monthly review.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

• Brand Name: UNKNOWN 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: 7765525
• MDR Text Key: 117001228
• Report Number: 2015691-2018-03275
• 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
• Report Date: 07/17/2018

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: 09/12/2018
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 09/12/2018; 07/23/2020
• Supplement Dates FDA Received: 09/27/2018; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 DA
• Patient Weight: 3