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

Model Number MHD6AZ

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

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

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

One flotrac - vamp adult kit was returned for examination.The pressure tubing was found detached from the bond joint that connects with the vamp adult reservoir stopcock.The tubing was bent near the point of detachment.Indications of bonding solvent was evident on locations of the tubing bond surface area.Both sensors of the flotrac unit zeroed and sensed pressure accurately on a vigileo and pressure monitor respectively.Lot number was not provided, therefore review of the manufacturing records could not be completed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.It is common clinical practice to inspect all products before usage.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, they are used in critical care units or ors where patients are closely monitored.If the pressure tubing becomes detached during use, it will affect the pressure waveform, which will immediately alert the clinician to begin the troubleshooting process.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.In this complaint, the scope of patient involvement is unknown.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

A flotrac system was returned to our decontamination laboratory with no associated complaint documented.Attempts are being made to the hospital to obtain additional event details but at this time there is no information available to report.A supplemental report will be submitted if any additional information is obtained.

Manufacturer Narrative

On (b)(6) additional information was obtained verifying that the product was model number mhd6az.

Manufacturer Narrative

The investigation of this flotrac sensor with a vamp concluded that a potential root cause of detached pressure tubing could be related to an incorrect solvent bonding execution during the assembly process.Personnel acknowledgement was conducted at the manufacturing site to prevent recurrence of this type of complaint.

Manufacturer Narrative

Additional follow up with the customer indicated that the complaint description is as follows: it was reported that during use, the pressure tubing of the flotrac/vamp system disconnected resulting in 5 milliliters of blood loss.There was no consequence for the patient.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

• Brand Name: FLOTRAC SENSOR WITH VAMP SYSTEM
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• MDR Report Key: 7831015
• MDR Text Key: 119152806
• Report Number: 2015691-2018-03610
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• PMA/PMN Number: K043065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MHD6AZ
• Device Catalogue Number: MHD6AZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 47