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

Model Number CK1336VOPL

Device Problem Particulates (1451)

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

Event Date 10/05/2016

Event Type  malfunction  

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.

Event Description

It was reported that an unknown red material was found inside the vamp flex reservoir during priming before use.No contamination was noticed inside the saline bag while preparing the bag.The lot number could not be identified.There were no patient complications reported.

Manufacturer Narrative

Received one vamp flex with pressure tubing.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.One red particulate was observed inside vamp flex reservoir during visual examination.The line was fully primed and then plunger of vamp flex was pushed to closed position, but the particulate remained inside of the vamp flex reservoir.Afterwards, the vamp flex was shut-off using the reservoir stopcock and the whole line was flushed continuously for 5 minutes.There was no visible particulate flushed out from the unit.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.In the complaint report, the particulate was discovered during priming of the system.The particulate was removed from vamp flex reservoir and sent to chemistry for analysis.A second supplemental will be submitted upon the chemistry results.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: DISPOSABLE 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: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 6064671
• MDR Text Key: 58718122
• Report Number: 2015691-2016-03218
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/06/2016

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 Model Number: CK1336VOPL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 10/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2016
• 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