MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CUSTOM DEFINED PRODUCT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number TC2605S01_

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Injury (2348)

Event Date 07/13/2015

Event Type  Injury  

Manufacturer Narrative

Unfortunately, we did not receive the sample for examination in our product evaluation laboratory.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Without return of the product, we are unable to perform a complete investigation into the root cause of the reported event.At this time, we cannot confirm the reported issue.

Event Description

It was reported that after the pressure measurement was completed with the kit still connected to the patient, the customer intentionally disassembled the kit and took off the dpt from the kit.However, the pressure bag was connected to the saline bag so the remaining 2000cc of saline was infused into the patient all at once.After the saline was infused into the patient, symptoms such as aphasia were noted and an epidural hematoma was found, which led to an surgical procedure.The operation was completed and the patient was stable.It was further stated that the incident was caused by a mishandling of the device and there was no malfunction on the device itself.The device was discarded by the hospital and will not be available for evaluation.

• Brand Name: CUSTOM DEFINED PRODUCT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• 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: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4988667
• MDR Text Key: 22488074
• Report Number: 2015691-2015-01992
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 07/13/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: TC2605S01_
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2015
• 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