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

Model Number PX266C

Device Problems Excess Flow or Over-Infusion (1311); Failure to Shut Off (2939)

Patient Problems Hypervolemia (2664); No Code Available (3191)

Event Date 08/16/2018

Event Type  Injury  

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 and device history results when received.

Event Description

During use of a disposable pressure transducer, it was reported that after the flush device was activated it did not shut off and the 3 kilogram patient received 400cc bolus in five minutes.The patient¿s surgery was cancelled.The patient was able to be stabilized and there was no report of any patient injury due to this event.Additional information as to the diagnosis of the patient or the planned surgery has not been able to be obtained to date.

Manufacturer Narrative

One single dpt kit with an attached trifurcated iv set and iv bag were returned for examination.The reported event of "pull tab it would not shut off" was not confirmed.The kit was primed and flushed without any problem.The flush device functioned (opened and closed) properly.The poppet closed off the flush path properly.Leakage was not detected from the returned kit during a leak test.The flow rate through the flow restrictor was measured and passed specification per edwards instructions for use.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.A review of the manufacturing records indicated that the product met specifications upon release.Invasive procedures involve some form of patient risk.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the potential complications.Additionally, these products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise.Invasive procedures involve some patient risks.An incorrect flow rate on a dpt can result in significant unintended fluid delivery which can pose a risk to the patient.In this event, the patient¿s surgery was cancelled.Further information as to the patient's current condition has not been able to be obtained to date.It is not known if some user or procedural factors may have contributed to the 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 capa-20-00141.

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• 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: 7850773
• MDR Text Key: 119374181
• Report Number: 2015691-2018-03691
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2020
• Device Model Number: PX266C
• Device Catalogue Number: PX266C
• Device Lot Number: 61372830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 09/06/2018; 07/23/2020
• Supplement Dates FDA Received: 09/19/2018; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 3