MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY HFO W/TRILLIUM 511T; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 95215

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Anemia (1706); Coagulation Disorder (1779); Renal Failure (2041)

Event Date 06/16/2014

Event Type  Injury  

Event Description

Medtronic received information indicating that during a bypass procedure, an arterial po2 of 50% was observed with a fio2 of 100% while using an affinity nt hollow fiber oxygenator (medwatch 2184009-2014-00051).The perfusionist replaced the oxygenator with a second affinity nt (this report), but the same arterial po2 of 50% was observed.The second device was used for the remainder of the case.Upon completion of the case, the patient presented with severe hypoxemia and anemia.A blood transfusion of seven units was administered.The patient was transferred to an intensive care unit (icu) in stable condition.As of (b)(6) 2014, the patient remained in the icu with coagulopathy and acute renal failure.The oxygenators were returned to medtronic for analysis.

Manufacturer Narrative

Follow-up report submitted to provide analysis and investigation information.Analysis: upon receipt at medtronic's quality laboratory, visual inspection showed no physical damage or abnormalities.The device was cleaned and subject to performance testing.Pressure integrity testing shows no internal or external leaks when run at three liters/minute with 23 psig of back pressure for ten minutes.The device was sent to the blood lab for further performance testing.Testing was conducted at a 1:1 ratio (7 liters/minute blood and gas flows) and the results were compared to historical test results of other used trillium coated affinity nt oxygenators.Testing showed that the device performed as expected when compared to other used devices.Conclusion: the product event could not be confirmed because the device performed as expected during product return analysis, indicating that the device performance did not contribute to the product event.(b)(4).

Manufacturer Narrative

The oxygenators have been received at medtronic and are currently being cleaned to allow blood performance testing to be performed.Upon completion of returned product analysis and medtronic's investigation, a supplemental report will be filed.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: AFFINITY HFO W/TRILLIUM 511T
• Type of Device: OXYGENATOR, 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: 3936325
• MDR Text Key: 4536656
• Report Number: 2184009-2014-00052
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K973760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Model Number: 95215
• Device Catalogue Number: 95215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00037 YR