MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY CP CENTRIFUGAL PUMP; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number CBAP40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Acidosis (2482)

Event Type  Injury  

Manufacturer Narrative

Age or date of birth, sex, weight: are unavailable as this information was provided as part of a post market clinical follow-up survey.The event date is unavailable as this information was provided as part of a post market clinical follow-up survey.Lot number is unavailable as this information was provided as part of a post market clinical follow-up survey.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information through a post market clinical follow-up (pmcf) survey that following use of the centrifugal pump at an unspecified time, hypercarbia and acidosis related to the device occurred.

• Brand Name: AFFINITY CP CENTRIFUGAL PUMP
• Type of Device: TUBING, PUMP, 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: 9368354
• MDR Text Key: 167783596
• Report Number: 2184009-2019-00076
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CBAP40
• Device Catalogue Number: CBAP40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2019
• 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