MAUDE Adverse Event Report: PERFUSION SYSTEMS FUSION HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BB811

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Infarction, Cerebral (1771); Paralysis (1997)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

Medtronic is unable to determine a relationship between the product and patient outcome at this time, as no device has been returned to date.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that after the start of a bypass procedure, the customer observed different readings than they were accustomed to while using this fusion oxygenator.After troubleshooting, the readings returned to normal and procedure was completed.Post-operatively, a blood clot was found inside the oxygenator.The report indicates the patient suffered cerebral infarction and left hemiplegia post-operatively.It is unknown whether or not the oxygenator caused or contributed to the patient event.Medtronic has requested additional information detailing the readings observed, but no response has been received to date.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality assurance laboratory, there was evidence of clotting in the fiber bundle of this oxygenator.Conclusion: the examination of the oxygenator showed the fiber bundle was stained suggesting some type of protein build up, cryoprecipitate or cryofibrinogen which provides the evidence of clotting.With the available information at this time, medtronic is unable to determine a relationship between the alleged product issue and patient outcome.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Medtronic received information that after the start of a bypass procedure, the customer observed increased internal pressure and different "oxidation capabilities" than they were accustomed to while using this fusion oxygenator.After troubleshooting, the values returned to normal and the procedure was completed.Post-operatively, a blood clot was found inside the oxygenator.The report indicates the patient suffered cerebral infarction and left hemiplegia after the procedure, but the customer stated that they do not believe there is a causal relationship between the alleged product problem and patient outcome.

• Brand Name: FUSION 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6976667
• MDR Text Key: 90219248
• Report Number: 2184009-2017-00039
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/01/2019
• Device Model Number: BB811
• Device Catalogue Number: BB811
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 81 YR