MAUDE Adverse Event Report: MEDTRONIC IRELAND AFFINITY CP CENTRIFUGAL BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number AP40

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 e.Hospital details and healthcare professionals information not made available through this 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 pumps at an unspecified time, had the following reported event: allergic reaction, acute systemic suspected ethylene oxide (eto: sterilization gas).During this type of procedure there are multiple devices/instruments that may have been sterilized using eto gas, without further information we are unable to confirm if this pump was the cause of the reported reaction.Respondent says the centrifugal pump performed as expected.Facility, initial reporter, lot numbers and event date were not provided as part of this post market clinical follow-up (pmcf) survey.

• Brand Name: AFFINITY CP CENTRIFUGAL BLOOD PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9327513
• MDR Text Key: 166546796
• Report Number: 2184009-2019-00069
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K132712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: AP40
• Device Catalogue Number: AP40
• 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