MAUDE Adverse Event Report: CONVATEC, INC. ABVISER - INTRA ABDOMINAL PRESSURE MONITOR DEVICE ; DEVICE, CYSTOMETIC, HYDRAULIC

Model Number ABV321

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

The intensive care unit (icu) nurse reported an abviser was placed on a pt on (b)(6) 2014 to monitor post operative abdominal pressure after gynecologic surgery of lysis of adhesions of a cyst and no urine output after the surgery.The icu nurse further reports waiting one (1) to three (3) minutes after saline solution was instilled into the abviser noting the auto-valve did not open; the abviser was discontinued and a new abviser was placed on the pt.The icu nurse reports there was no harm to the pt nor further medical intervention given.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.There were no reports of the pt being harmed as a result of this malfunction.Additional pt/event details have been requested.Should additional info become available, a follow-up report will be submitted.Reported to the fda on 01/06/2015.

Manufacturer Narrative

Additional information was received on august 26, 2015.The returned unit had no lot number therefore the third party manufacturer performed a review of the historical batch records for abv301 which showed all testing met specification.The returned unit was evaluated and did not function properly.Unit was examined under a microscope and it showed the valve assembly was correctly assembled but the opening was completely clogged with an unknown particle which was a soft yellow and brown material.The exact source of the particle could not be determined due to its small size.No previous investigations are available.After a thorough review of the returned particle and batch review no discrepancies were discovered.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required and this complaint will be closed.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: ABVISER - INTRA ABDOMINAL PRESSURE MONITOR DEVICE
• Type of Device: DEVICE, CYSTOMETIC, HYDRAULIC
• Manufacturer (Section D): CONVATEC, INC. ; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4398087
• MDR Text Key: 5121732
• Report Number: 1049092-2015-00006
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ABV321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2015
• 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
• Treatment: INTRAVENOUS LACTATED RINGERS; PERCOCET; NORMAL SALINE; SODIUM BICARBONATE; MORPHONE; MYLICON; AMARYL; NORVASC; AOSYN; BENAZAPRIL; DUCOLAX; INTRAVENOUS DEXTROSE 5% NORMAL SALINE; LOVENOX; BYASTOLIC; NOVOLOG; INSULIN
• Patient Age: 84 YR
• Patient Weight: 68