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

Model Number CK1206Y04

Device Problems Break (1069); Detachment of Device or Device Component (2907); Gas/Air Leak (2946)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

One double merit flush kit with an iv set and pressure tubing were returned for examination.The reported event of broken issue was confirmed.The male luer of the merit flush device was broken at the solvent bond joint to the female luer of the three-way stopcock on the blue line.The cross surfaces of the broken luer appeared uneven and rough.No other visible defect/damage was observed from the kit.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 use.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.If the pressure tubing becomes detached/or broken at a connector during use, it will affect the pressure waveform, which will immediately alert the clinician to begin the troubleshooting process.The ifu states: ¿do not allow air bubbles to enter the setup, especially when monitoring arterial pressures.¿ ¿if all air is not removed from the bag, air may be forced into the patient¿s vascular system when the solution is exhausted.¿ ¿significant distortion of the pressure waveform or air emboli can result from air bubbles in the setup.¿ ¿periodically check fluid path for air bubbles.Ensure that connecting lines and stopcocks remain tightly fitted.¿ air emboli is a stated complication in the ifu.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.It is unknown whether user or procedural factors played a role in this event.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.The 510k is not available as this device is sold in (b)(4) only.

Event Description

It was reported that air inclusion was observed with the pressure tubing during use of this disposable pressure transducer kit.The bonding connector between the dpt and zero stopcock was broken off and pressure tubing included air at the distal end.The customer locked zero stopcock immediately.There were no change with vital signs and respiratory condition of the patient.However, as air embolism was suspected, ct inspection was performed.The customer re-checked the patient and confirmed there was no air embolism and there were no other patient complications.Patient demographics were unable to be obtained.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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
• MDR Report Key: 9199654
• MDR Text Key: 195043857
• Report Number: 2015691-2019-03819
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CK1206Y04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention