MAUDE Adverse Event Report: PERFUSION SYSTEMS CARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number CB511

Device Problem Fluid Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/24/2021

Event Type  Injury  

Manufacturer Narrative

Medtronic investigation: the information provided indicated the leak did not occur until well after the devices 6 hour use indication. Under this guidance, the fda is allowing temporary limited modifications to the indications of certain fda-cleared or fda-approved cardiopulmonary devices without prior submission of premarket notification. These modifications are allowed, in light of the public health emergency, when they do not create an undue risk. This indication modification is in effect for the duration of the public health emergency related to covid-19, as declared by the department of health and human services (hhs). Temporary limited modifications to the indication: "in accordance with the fda guidance, the devices listed have a modified indication for use during the covid-19 public health emergency. This indication modification has not been cleared or approved by the fda, but shall apply temporarily to the device models listed in this supplement: the device can be used for longer than 6 hours in an extracorporeal membrane oxygenation (ecmo) circuit to treat patients who are experiencing acute respiratory or acute cardiopulmonary failure. " it is likely the prolonged used contributed; however, medtronic cannot confirm or deny if the length of the procedure contributed to the reported inci dent. No device was returned for analysis, so a root cause cannot be determined, but pictures were provided that confirm the report. Pict ures provided indicate a 'white' foam from the fiber bundling indicating protein breakthrough occurred. Affinity nt oxygenator fiber/plasma leaks are an extremely low occurring phenomena with devices made with microporous membrane. The product is designed to maximize the performance and robustness of the oxygenator and medtronic uses extremely sophisticated techniques for identifying leaks in the production process. As the device was not returned and no valid serial number was provided, a dhr review was not possible. This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary. Trends for issues with this product are reviewed at quarterly quality meetings. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the customer reported the custom pack's fusion oxygenator was oozing blood and there were a lot of bubbles on the outside of the device. 200ml of blood was lost per hour, and a blood supplement was needed to maintain capacity. The total blood loss (ml) due to leakage was about 800ml. The device was replaced. There was no adverse effect to the patient. Additional information: ecmo assistance was carried out on january 21 until a leak was found on the 24th, a total of 3 days. There was no damage to the device, the packaging or other contents within the package. There was no visible air in the system/tubing.

Manufacturer Narrative

Correction to b5: "the customer reported the custom pack's affinity nt oxygenator was oozing blood". Previously reported incorrectly as a "fusion oxygenator". If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the customer reported the custom pack's affinity nt oxygenator was oozing blood and there were a lot of bubbles on the outside of the device. 200ml of blood was lost per hour, and a blood supplement was needed to maintain capacity. The total blood loss (ml) due to leakage was about 800ml. The device was replaced. There was no adverse effect to the patient. Additional information: ecmo assistance was carried out on january 21 until a leak was found on the 24th, a total of 3 days. There was no damage to the device, the packaging or other contents within the package. There was no visible air in the system/tubing.

• Brand Name: CARMEDA AFFINITY NT HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11391325
• MDR Text Key: 244381476
• Report Number: 2184009-2021-00008
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K191029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CB511
• Device Catalogue Number: CB511
• Device Lot Number: 219741208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/01/2021 Patient Sequence Number: 1