MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY CP PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number BBAP40

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

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Event date was not made available through this survey.Hospital details and healthcare professionals information not made available through this survey.The country the information came from was provided and that has been included.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 bbap40 centrifugal pump at an unspecified time an acute systemic allergic reaction to ethylene oxide occured.During this type of procedure there are multiple devices and instruments that may have been sterilized using ethylene oxide gas, without further information we are unable to confirm if this centrifugal pump was the cause of the reported reaction.Respondent says the centrifugal pump performs as expected.

• Brand Name: AFFINITY CP PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 9327596
• MDR Text Key: 166561993
• Report Number: 2184009-2019-00070
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K132712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BBAP40
• Device Catalogue Number: BBAP40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2019
• 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