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

Model Number CBAP40

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2021

Event Type  malfunction  

Manufacturer Narrative

Medtronic investigation: complaint is not confirmed for decoupling.The complaint device was not returned for analysis, and review of the device history record found no abnormalities during the manufacturing process that would cause or contribute to the reported event.The root cause of the issue could not be determined.Review of the complaint file determined that the device was used for greater than six hours.Per supplemental ifu part number (b)(4), extended use was deemed to not produce undue risk.There were no patient adverse effects.Trends for issues with this product are reviewed at quarterly quality meetings.If additional information is received, the investigation will be reopened if deemed necessary.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the customer reported that the ap40 centrifugal pump decoupled.The centrifugal pump was changed out in 30 seconds.There was no adverse effect to the patient.Additional information: the cps was in use for 90 hours before the cone decoupled.The rpms were 3160.The pump was in a console 560 with external drive motor.There was no noise coming from the pump or console.The pump had not been damaged in any way.The prefusion records were requested but were unavailable.

• Brand Name: AFFINITY CP CENTRIFUGAL 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11733327
• MDR Text Key: 267417085
• Report Number: 2184009-2021-00024
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CBAP40
• Device Catalogue Number: CBAP40
• Device Lot Number: 221398245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: No
• 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