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

Model Number PXMK2041

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2016

Event Type  malfunction  

Manufacturer Narrative

We received one single dpt kit for examination.The reported event of contamination in the tubing was confirmed.A dark brown particulate was found inside of the iv tubing of the returned pressure monitoring kit.The particulate was located 25" distal from the drip chamber.The particulate, approximately 0.11"x0.04" in size, was attached to inner surface of the iv tubing and did not get flushed away during 5 minutes of flushing.The particulate was removed from the tubing and sent to chemistry for further analysis.A supplemental report will be forthcoming with the device history record and chemistry results.With dpt sets, it is common for the clinician to check for air or particulates while priming the line for use.Additionally, these products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise.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.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.

Event Description

It was reported that before use there was a foreign body observed between the iv set and the dpt (disposable pressure transducer) in the clear tubing.There was no allegation of patient injury.Device was available for evaluation.Inquired of patient demographics, unable to be obtained.

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specifications upon release.Per chemistry results the spectrum of the unknown dark brown particulate showed similar absorption characteristics to a pvc (polyvinyl chloride) colorite-like material.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

• 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: 6172447
• MDR Text Key: 62317174
• Report Number: 2015691-2016-03694
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/21/2016

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: 07/15/2018
• Device Model Number: PXMK2041
• Device Lot Number: 60464465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2016
• 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