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

Model Number DPTUNKNOWN

Device Problems Fluid/Blood Leak (1250); 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 evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.

Event Description

It was reported that, during use of this disposable pressure transducer, the male pressure tubing connector came off of the extension tubing.It appears that the glue/seal did not hold.This resulted in the patient bleeding from the arterial line.The lot number is not available. it was later updated that more than a few drops of blood had leaked and the bed sheets were soaked, but it is unsure how many ml of blood was lost.There is no patient injury reported.Patient demographics are not available.

Manufacturer Narrative

The returned pressure tubing was not an edward product.No further analysis will be performed.

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: 10370949
• MDR Text Key: 204788179
• Report Number: 2015691-2020-12948
• 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,Followup
• Report Date: 07/17/2020

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 Model Number: DPTUNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 08/06/2020; 07/23/2020
• Supplement Dates FDA Received: 09/03/2020; 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1