MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR VOLUMEVIEW KIT; PROBE, THERMODILUTION

Model Number VLV8R520

Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specification at the time of release.Received one volumeview combo kit from reported model and lot number.The femoral catheter and venous injectate kits were still in sealed condition.However, the volumeview sensor kit was not returned.Components inside the shelf box were carefully removed and laid over a clean white sheet of paper during pre-decontamination visual examination.No hair particulate was found from the products.Each component from the returned package was examined under magnified glass during post-decontamination.There was no visible hair particulate found from the package.

Event Description

It was reported that a hair was observed inside the primary package of the femoral catheter.It was also noted that the packaging of the catheter was intact, but appeared to be open.The kit was not used on the patient as it was observed during restocking.

• Brand Name: VOLUMEVIEW KIT
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco; 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610
• Manufacturer Contact: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5496153
• MDR Text Key: 40567526
• Report Number: 2015691-2016-00765
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• PMA/PMN Number: K100739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2017
• Device Model Number: VLV8R520
• Device Lot Number: 60144302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2015
• 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