MAUDE Adverse Event Report: DATASCOPE CORP. ADULT CPB CIRCUIT WITH HMO 71000; CARDIOPULMONARY DEVICE

Model Number BO-TOP 1201

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2011

Event Type  malfunction  

Event Description

The hosp rep reported that "the oxygenator leaked.The drip is coming off of the band that is closest to the quadrox.There is a white towel underneath it with blood all over it." a photo that the hosp rep provided showed that there was a leak at the quadrox inlet port.The hosp had placed their own tie on the product to continue the case.

Manufacturer Narrative

Based upon the returned component, it was determined that the leak was due to a crack in the quadrox inlet port at the base of the luer lock (see attached photo).The most probable cause of this issue is an impact to the luer lock.This could have occurred if the component saw high impact forces during shipping, during assembly, or if the inlet port was subjected to a high force during use.Since all of the quadrox parts are leak tested 100% as part of the mfr process in germany, it is not believed to be an issue with the mfr of the component.Upon further review of the lot history record for this work order, there was no indication of any issues that would have caused this defect and there are no previous complaints for this type of defect, which is why this is considered an isolated incident and will be recorded and reviewed for any future trends.(b)(4).

• Brand Name: ADULT CPB CIRCUIT WITH HMO 71000
• Type of Device: CARDIOPULMONARY DEVICE
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ
• Manufacturer Contact: jason de sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 4093136
• MDR Text Key: 4758013
• Report Number: 2248146-2014-00387
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2013
• Device Model Number: BO-TOP 1201
• Device Catalogue Number: 701050968
• Device Lot Number: 13347-09
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/27/2011
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• 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