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

Model Number PX36N

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.A review of the manufacturing records indicated that the product met specifications upon release.

Event Description

It was reported that in the icu, in a (b)(6) patient who went through a cardiac surgery, 1000ml of heparinized saline was set through the pressure monitoring set (which is programmed to 30cc/hour) at 2pm.At 9pm, the heparin solution measurement was 900ml, three times more than the expected 300ml.The transducer was first used in the operation room to measure pressure and central venous pressure, during the surgery the pressure measurements were variable, from 70 to 45mmhg.After surgery, the same transducer was used, not for drug administration but to measure pressures and to keep the arterial line patient.The patient was discharged with stable parameters.The cardiology nurse indicated that during the hours when the issue with the transducer appeared, the patient had some blood loss but they managed to stabilize the pressure and the iv fluids.There was no allegation of patient injury.

• 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
• 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
• MDR Report Key: 6018880
• MDR Text Key: 57106410
• Report Number: 2015691-2016-03009
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: NU
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2016

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 Expiration Date: 03/31/2018
• Device Model Number: PX36N
• Device Lot Number: 60349151
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2016
• 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: 6