MAUDE Adverse Event Report: PERFUSION SYSTEMS FUSION HFO CARMEDA COATED; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number CB811

Device Problem Increase in Pressure (1491)

Patient Problems Hemorrhage/Bleeding (1888); Low Oxygen Saturation (2477)

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

Medtronic investigation complaint was not confirmed for the fusion oxygenator's high pressure.Analysis of the returned device was unable to replicate the reported incident.The returned oxygenator resulted in a typical (normal) blood side pressure drop of 168 mmhg at a flow rate of 7 l/min.This is used as a potential indicator for device performance from a restricted flow or high pressure drop perspective, and the results were as expected.The device history record was reviewed; devices are required to pass manufacturing inspections and specifications prior to release and no abnormalities were documented which would cause or contribute to the reported occurrence.Testing suggests the high-pressure excursion experienced may patient or clinically related.Other potential contributing factors include low heparin protocols, temperature extremes, or variability in heparin potency causing a faster decline in anti-coagulation than anticipated.There were no patient/clinical safety issues reported.The 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.Lot #: the oxygenator was part of the following perfusion pack.Two fusion oxygenator lots were available for these packs: 221036514 or 221062647.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the customer reported high pressure in the perfusion pack's fusion oxygenator.The d elta-pressure increased within a few minutes to 400 mmhg despite reduction in pump-flow from approximately 5 lpm to 3 lpm.Simultaneously, there was a malfunction in oxygenation of the blood.High pco2 and low po2, despite increasing sweep and fio2.The tubing set was replaced to continue the procedure.After priming, the customer started the hlm once again and had no problems during the operation.There were no reported adverse patient effects, however there was blood-loss of approximately 1500ml in the hlm-set that was replaced.Additional information: there was increasing pressure as soon as the customer started the hlm.10.000 iu heparin in 1200ml ringer acetate were used in prime/during the case.The pressure was measured in the circuit pre- and post-oxygenator.The temperatures pre- and post-oxygenator were 37°c during priming.Heparin dosing was monitored to achieve optimal therapeutic response using a hemochron signature elite.Act-value 430 sec.It was requested if a blood transfusion was required due to the event, but no information was available.

• Brand Name: FUSION HFO CARMEDA COATED
• 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: 11964448
• MDR Text Key: 267629855
• Report Number: 2184009-2021-00049
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K183490
• 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
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CB811
• Device Catalogue Number: CB811
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/09/2021
• 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