MAUDE Adverse Event Report: PERFUSION SYSTEMS "BIO PUMP PLUS, BPX80, STERILE"; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	95201
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Coma (2417)
Date of Event	01/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic is unable to confirm the relationship between the patient outcome and reported product issue at this time, as no product has been returned to date.The product is expected to return to medtronic for analysis.
Event or Problem Description
Medtronic received information that approximately 80 minutes into a case, the customer reported the flow from this bio-pump centrifugal pump suddenly went to zero.The customer did not use the handcrank on the bioconsole and instead put the tubing in the arterial roller pump within the heart-lung machine to address the issue.The patient was reported to be in a coma, without sedation, as a result of this issue.Additional information is being pursued by medtronic.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality assurance laboratory, visual inspection shows no outward signs of damage to the centrifugal pump.The device appears to have been rinsed out.There was no evidence of any clotting/fibrin observed inside the device.Performance analysis: during functional testing, no internal or external leaks were exhibited.The centrifugal pump functioned as expected and met specification during all functional tests.Medtronic's investigation is in progress.
Event or Problem Description
Medtronic received information that approximately 80 minutes into a case, the customer reported the flow from this biopump suddenly went to zero.The customer did not use the handcrank on the bioconsole and put the line in the arterial roller in the cardiopulmonary bypass machine to address the issue.The patient was reported to be in a coma, without sedation, as a result of this issue.Additional information: the patient was reported to have passed away on (b)(6) 2017 from cardiac arrest.
Additional Manufacturer Narrative
Perfusion and service records were requested several times from the perfusionist and hospital risk management; however, were not provided due to patient privacy.A review of complaint history (2007 through 2017) found no prior complaints associated with immediate pump stoppage.The risk management files and the device history records for this bpx80 bio-pump were reviewed and it was concluded that no design or manufacturing related failures were noted that would cause or contribute to the reported incident.Based on the limited information available, the root cause could not be determined, although clinical use is a potential cause.No further investigation will be conducted unless additional information relevant to this event is provided.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that approximately 80 minutes into a case, the customer reported the flow from this bio pump suddenly went to zero.The customer did not use the handcrank on the bioconsole and put the line in the arterial roller in the cardiopulmonary bypass machine to address the issue.The patient was reported to be in a coma without sedation as a result of this issue.Additional information: it was later reported that the passed away on (b)(6) 2017 from cardiac arrest.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: "BIO PUMP PLUS, BPX80, STERILE"
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 6342854
• Report Number: 2184009-2017-00011
• Device Sequence Number: 650657
• Product Code: DWE
• UDI-Device Identifier: 20613994406945
• UDI-Public: 20613994406945
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K973011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/17/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: 95201
• Device Catalogue Number: 95201
• Device Lot Number: 13161443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2017
• Initial Date Received by Manufacturer: 01/26/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 05/17/2017
• Initial Report FDA Received Date: 02/20/2017
• Supplement Report FDA Received Date: 03/14/2017; 06/09/2017; 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 55 YR
• Patient Weight: 70