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

Model Number PXMK2277

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 04/08/2017

Event Type  Injury  

Manufacturer Narrative

The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.A supplemental report will be forthcoming with the evaluation results when received.Lot or serial number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

As reported, during use of this disposable pressure transducer, bubbles were noticed in the pressure connector, just past the transducer.Nurse disconnected the line at the manifold, bubbles were flushed through and the pressure connector was then reconnected.Shortly after, the patient experienced hypotension and bradycardia, and it was noted that there were bubbles in the circuit.The physician suspected an air embolism.The patient was stabilized and there was no allegation of any injury.

Manufacturer Narrative

We received one single dpt with an attached bifurcated iv set for examination.The reported of "bubbles were noticed in the pressure connector, just past the transducer" was not confirmed.The pressure tubings were not returned with the kit and air bubbles were visible inside of the iv set.The kit was primed at pressure 45 mmhg and flushed at pressure 345 mmhg.All air bubbles were removed from the kit during flushing.No new air bubbles entered the kit during priming and flushing.In addition, no leakage was detected from the kit during leak test.The reported event was not confirmed.Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis.No actions will be taken at this time.Lot number was not provided, therefore review of the manufacturing records could not be completed.It is common clinical practice to inspect all products before usage.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.If desired, the clinician can exchange the system for another one, causing a minor delay in treatment or monitoring.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.

• Brand Name: 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 6539177
• MDR Text Key: 74252181
• Report Number: 2015691-2017-01188
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PXMK2277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 95