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

Model Number PXVMP160

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2014

Event Type  malfunction  

Manufacturer Narrative

We received one single dpt - vamp adult kit.Dry blood was evident on the plunger side of the blue seal and on the inside of the contamination shield.Blood was evident between the seal and reservoir.It was apparent that blood had leaked past the blue seal to plunger side and out of reservoir cap into contamination shield.A simulated use test was performed to the vamp system in attempt to recreate how blood passed the seal into plunger side.No leakage was detected past the seal during simulated use test which followed ifu instruction.It was instructed by ifu to smoothly and evenly move the plunger at rate of 5ml per 3-5 seconds during aspiration and injection of blood from the reservoir.The seal and attached plunger were removed from the reservoir for visual examination.There was no apparent defect on the seal.It was not able to compare the seal dimensions with drawing because the seal was not in original condition (being compressed inside the reservoir).Leakage across the seal of the vamp reservoir was not able to be recreated in the laboratory during product evaluation.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

Event Description

It was reported that the vamp adult kit was observed to have blood above the seal.It was also indicated that the seal looks like it was compromised.There were no patient complications reported.

Manufacturer Narrative

The unit is expected to be returned for evaluation; however, it has not yet been received.A review of the manufacturing records could not be completed without a lot number.A supplemental report will be submitted when the evaluation is complete.

• Brand Name: DISOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4276478
• MDR Text Key: 12680510
• Report Number: 2015691-2014-02794
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PXVMP160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2014
• 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