MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP PERICARDIAL/INTRACARDIAC SUMPS; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Model Number 12112

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2014

Event Type  Injury  

Event Description

Medtronic received information that during use in a procedure, the suction portion of this intracardiac sump came off from the device and was resting in the patient's chest.The section was retrieved and the product was replaced.There were no adverse patient effects as a result of the disconnection or recovery of the piece.

Manufacturer Narrative

Upon receipt at medtronic's quality assurance laboratory, visual analysis confirmed the disconnection.There appeared to be damage to the tubing and sump at the interface where the disconnection occurred.After cleaning, further visual examination under magnification confirmed the presence of adhesive residue on the connection.The product has been sent to the contract manufacturer of this device for further examination.Upon completion of the investigation by medtronic's quality engineers and the contract manufacturer, a supplemental report will be filed.(b)(4).

• Brand Name: DLP PERICARDIAL/INTRACARDIAC SUMPS
• Type of Device: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3959411
• MDR Text Key: 4611564
• Report Number: 2184009-2014-00057
• Device Sequence Number: 1
• Product Code: DTS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K850385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 12112
• Device Catalogue Number: 12112
• Device Lot Number: 2013041096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2013
• 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): Required Intervention