MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS MEDTRONIC TUBING PACK; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BB8N60R3

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 09/08/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality assurance laboratory, analysis confirmed that the tubing and connector could be separated without significant effort.The condition/security of the connection prior to the reported event could no longer be evaluated.Conclusion: the investigation is currently in progress.A supplemental report will be filed upon completion of the investigation if new or additional information is received.(b)(4).

Event Description

Medtronic received information indicating that a patient, who had been on both right and left ventricular assist devices for approximately 4 days, was taken back to or to clear a clot on the 4th day post operative.On return to the nursing unit, the patient was being re-positioned in bed when the tubing became disconnected from a fitting within this tubing pack.The patient was attended to when it occurred, so staff were able to respond quickly to control bleeding and connect the patient to a ventricular assist device.The patient did require blood transfusions to correct the loss.No additional adverse patient effects were reported.

Manufacturer Narrative

Conclusion: medtronic's quality engineers were unable to replicate the reported issue.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.(b)(4).

• Brand Name: MEDTRONIC TUBING PACK
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland drive; 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: 5325020
• MDR Text Key: 34303621
• Report Number: 2184009-2015-00123
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BB8N60R3
• Device Catalogue Number: BB8N60R3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 00044 YR
• Patient Weight: 86