MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET; PRESSURE MONITORING KIT

Model Number T001691A

Device Problem Inaccurate Flow Rate (1249)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2021

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 when received.

Event Description

As reported, during use in patient, of this disposable pressure transducer (dpt), there was incorrect flow rate of fluid.A 500ml saline bag (nacl 9mg/ml) was administered too fast as it was administered during 7 hours.This issue occurred after moving the patient from or to post-op with an already connected dpt attached with an arterial line and to which a new nacl bag was connected and pressurized at 300mmhg.The bed and the floor were checked and it was confirmed that no leakage occurred.To solve the issue, a new pressure set was used and the issue was solved.In addition, it was also confirmed that the correct infusion rate with 300mmhg should have been 3ml/hr and no pump was connected.There was no allegation of patient injury.

Manufacturer Narrative

One dpt- vamp plus kit was returned for evaluation.Dry blood was visible at distal tubing connector.The reported event of flow rate issue was confirmed and concluded to be due to leakage.The set was able to prime throughout the kit without any problem during priming.However, leakage was noticed during flow rate testing.Red dye was manually injected through the dpt housing to trace the leak path.Leakage occurred through a channel across bond area between flow restrictor and dpt housing.No other visible damage or leakage was observed from returned kit.The lot number was not provided thus a device history record was not reviewed.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.When using a disposable pressure transducer, incorrect flow rates that result in significant unintended fluid delivery poses a risk to the patient.Per the ifu, 'excessive flow rates may result from pressures greater than 300 mmhg.This may result in a potentially harmful increase in blood pressure and fluid overdose.' these devices are used by highly trained clinicians well versed in mitigating procedural issues.It is unknown whether user or procedural factors 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 a part of the monthly review.

Manufacturer Narrative

The reported event was confirmed and concluded to be supplier related.The supplier was notified of the complaint.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.

• Brand Name: PRESSURE MONITORING SET
• Type of Device: PRESSURE MONITORING KIT
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• MDR Report Key: 11379356
• MDR Text Key: 245465738
• Report Number: 2015691-2021-01450
• 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: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: T001691A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2021
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 96