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

Model Number BBAP40

Device Problems No Flow (2991); Noise, Audible (3273)

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

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

Medtronic investigation: the returned device impeller was loose inside the device.Visual inspection showed evidence of clotting/fibrin on both the upper and lower pivot.Additional inspection showed evidence of damage to the upper pivot.The device was tested per specification.The device was run on a bio-console from 0-4000 rpm¿s, using fluid.A noise level greater than 75 db was recorded, specification is less than 68 db.When the device was operating at the higher rpm's the impeller appeared to be pushed so far into the upper bushing that it started to decouple and appeared to slow down.The customer declined producing the anticoagulation record and confirmed it would show that heparin was only given when the patient was cannulated.It is noted that if the upper pivot bearing is not fully submerged in fluid, for example in the presence of a blood clot, this will cause the upper pivot bearing to degrade.Saline or blood is required during use to cool the ceramic bearing inside the pump.The excessive noise is attributed to the failing pivot bearing.Trends for issues with this product are reviewed at quarterly quality meetings.This investigation was completed with the information that was provided.If additional information is received this investigation will be reopened if deemed necessary.No further actions to be taken at this time.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the customer reported a covid patient was on ecmo for two weeks.Perfusion was called stat to the patient's bedside and discovered the icu nurse was hand-cranking the centrifugal pump from the bio-console, which had stopped flowing.The nurse reported that the console/drive was making a grinding noise before the flow stopped.The perfusionist turned the pump off and then on, and then reseated the pump on the drive motor.Flow was re-established, but the pump/motor was still making a grinding noise.The decision was made to change out the entire ecmo circuit.The circuit was drained, including the pump, and no thrombus was discovered.There was no adverse effect to the patient.Additional information received from the medtronic sales rep: the pump was used for the entire 2 weeks the patient was on ecmo.The customer declined producing the anticoagulation record and confirmed it would show that heparin was only given when the patient was cannulated.Then, they would keep the ptt at 45-60.The customer estimated the handcrank was in use for a few minutes only.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11170055
• MDR Text Key: 226813550
• Report Number: 2184009-2021-00001
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: BBAP40
• Device Catalogue Number: BBAP40
• Device Lot Number: 220357895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2020
• 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): Required Intervention