MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BO-VBT 160-J#BO-VENOUS BUBBLE TRAP- STERILE; VBT (VENOUS BUBBLE TRAP)

Catalog Number 70104.8887

Device Problem Suction Problem (2170)

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

Event Type  malfunction  

Event Description

It was reported that during use on a pt.Accumulation of air was observed on the lower side of the de-airing cock.Air accumulation was observed soon after manipulating the de-airing cock.The customer suspects the failure is due to the back-flow valve and/ or the product housing.Device use was continued with no reported pt effect.Blood flow rate: 3.6l/min.Aspiration pressure: -56mmhg".(b)(4).

Manufacturer Narrative

(b)(4).A health hazard eval was initiated and the hazard has been defined.Based on new info available (b)(4) 2014, a re-assessment of the reporting obligation was performed and this event was determined to be reportable.Maquet cardiopulmonary is aware of similar complaints and an internal process (b)(4) was initiated to determine the root- cause and implement the appropriate corrective action.A supplemental medwatch will be submitted when add'l info becomes available.

• Brand Name: BO-VBT 160-J#BO-VENOUS BUBBLE TRAP- STERILE
• Type of Device: VBT (VENOUS BUBBLE TRAP)
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond dr; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 4219065
• MDR Text Key: 4999770
• Report Number: 8010762-2014-00295
• Device Sequence Number: 1
• Product Code: DTP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2014,08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Catalogue Number: 70104.8887
• Device Lot Number: 92125382
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/06/2014
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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