MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR FLOTRAC SENSOR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number MHD8S

Device Problem Particulates (1451)

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

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

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 in the fluid lumen of the connector of the three way stopcock after priming before use.There were no patient complications reported.

Manufacturer Narrative

Per chemistry study (b)(6) the ir spectrum of the unknown red materials showed similar absorption characteristics when comparing to thermoplastic siloxane elastomer like material.

Manufacturer Narrative

We received one flotrac sensor with attached coiled iv tubing and paper band.A review of the manufacturing records indicated that the product met specification at the time of release.An unknown red particulate was found inside the flotrac zero-stopcock.A second red particulate was also found inside the pressure tubing male connector.Both particulates were able to move from their original position after the kit was continuously flushed at high pressures for five minutes.However, both particulates were still within the tubing of the pressure monitoring kit at the end of the five minute flush.Chemistry results are pending and follow up report will be submitted upon completion.

Manufacturer Narrative

Manufacturer report number 2015691-2016-02368 was previously submitted to communicate the results of the ir chemistry testing of red particulate matter observed in the fluid lumen of the three-way stopcock.As reported, the ir spectrum of the red material showed similar absorption characteristics to thermoplastic siloxane elastomer-like material.An investigation of the manufacturing process was performed in an attempt to isolate the source of the red particulate matter.The manufacturing process was assessed to identify red materials utilized during manufacturing.Chemistry testing was performed for all ¿red material.¿ the testing and outcome of the investigation supports that ¿red o-rings¿ utilized during the final electrical testing of the device, contain a similar composition as the particles reported under this complaint.It was concluded that this component was the most-likely source of the contamination.A historical review for similar complaints identified one (1) other complaint for the past year; the occurrence rate is (b)(4) with no patient compromise reported for either non-conformance.The suspect device undergoes manual assembly and visual inspection during manufacturing.Employees are trained at the beginning or the shift on the corresponding sequence established by procedures which include the guidelines to be followed in properly executing the operations and inspections.Documented communication for ¿awareness¿ of this issue was provided to all associated manufacturing personnel.

• Brand Name: FLOTRAC SENSOR
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 5831677
• MDR Text Key: 50725372
• Report Number: 2015691-2016-02368
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: E130471
• 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,Followup,Followup
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MHD8S
• Device Lot Number: 60220359 OR 60242863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2016
• 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