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

Model Number CK3311VP01_

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Received one vamp plus with attached pressure tubing.The report of flow rate issue was not able to be confirmed during evaluation since no dpt or flush device (non-ew pressure monitoring kit) was returned for evaluation.General evaluation was performed to the returned vamp plus unit.It was able to prime throughout the unit without indication of occlusion or flow restriction.It was also able to flush entire unit without any issues.There was no leakage observed from the unit during leak testing and no visible damage/defect was found.The plunger of the vamp plus functioned properly.

Event Description

It was reported that an edwards vamp plus kit was connected to a non-edwards pressure monitoring kit.It was further stated that from 8pm on (b)(6) 2016, a pressurized bag containing 500ml of maltose-lactated ringer's solution and 2500 units of heparin was administered at the flow rate of 3ml/hr.However, only 70ml of solution remained inside the pressurized bag when it was checked the following morning.The entire kit was exchanged.There were no patient complications reported.

• 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: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5563570
• MDR Text Key: 42949543
• Report Number: 2015691-2016-01143
• 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: Other
• Type of Report: Initial
• Report Date: 03/11/2016

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: CK3311VP01_
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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