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

Model Number DPTUNKNOWN

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation as it was discarded by the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.The lot/serial number was not provided thus a device history record was not reviewed.  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.In this case, there were no patient impact.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 a part of the monthly review.

Event Description

It was reported that, during use of a disposable pressure transducer, the male pressure tubing connector came off of an extension tubing.It appears the glue/seal did not hold.The lot number is not available.This resulted in the patient bleeding from their arterial line.The amount of blood loss is unknown but there is no patient injury reported.  patient demographics are not available.

Manufacturer Narrative

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: 10370701
• MDR Text Key: 204787467
• Report Number: 2015691-2020-12944
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DPTUNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1