MAUDE Adverse Event Report: CONVATEC, INC. ABVISER AUTOVALVE VALVE IAP MONITORING DEVIC; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number ABV301

Device Problem Defective Component (2292)

Patient Problem Death (1802)

Event Date 10/09/2014

Event Type  Death  

Event Description

It was reported the intra-abdominal pressure monitoring device was used on a newborn patient.The patient was reportedly suffering from "many complications" and had been previously admitted to the hospital's intensive therapy unit.On (b)(6) 2014, a nurse at the facility infused six milliliters in the pressure monitoring system and noted the autovalve did not activate.The nurse then unfused an additional two milliliters and again the autovalve did not activate.The patient reportedly expired on (b)(6) 2014.The device had been in use for thirty-nine days.

Manufacturer Narrative

Based oin the available information, this event is deemed to be a death; however there is no allegation the death is device related.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Reported to the fda on 12/16/2014.

• Brand Name: ABVISER AUTOVALVE VALVE IAP MONITORING DEVIC
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak,interim assoc d ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4343298
• MDR Text Key: 5203458
• Report Number: 1049092-2014-00622
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/19/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2016
• Device Model Number: ABV301
• Device Lot Number: 130427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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
• Patient Outcome(s): Death
• Patient Weight: 6