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

Model Number VO3304TTPL01

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2017

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 and device history results when received.

Event Description

It was reported that an unknown dust like particulate was found inside the pressure tubing during priming before use.It was indicated that the particulate may have moved due to the saline inside of the tubing.Occurrence date is unknown.There were no patient complications reported.Inquired of patient demographics.Unable to be obtained.

Manufacturer Narrative

We received one triple flothru dpt-vamp flex kit with an iv set and pressure tubing for examination.The reported event of ¿unknown dust like particulate was found inside of the pressure tubing¿ was not confirmed.The only mark/stain noticed on the tubing is where the customer marked in black ink the location of the particulate.However, no visible particulates was observed from the location during a visual examination.The kit was flushed continuously for 5 minutes, but no visible particulates were flushed out from the kit.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.With dpt sets, it is common for the clinician to check for 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.No corrective or preventative actions are required at this time.

• Brand Name: CUSTOM DEFINED 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 ; 9492506423
• MDR Report Key: 6355205
• MDR Text Key: 68216275
• Report Number: 2015691-2017-00476
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/02/2017

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: 07/01/2018
• Device Model Number: VO3304TTPL01
• Device Lot Number: HL0891MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/03/2017
• 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