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

Model Number AP40

Device Problems Obstruction of Flow (2423); Noise, Audible (3273)

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

Event Date 06/08/2021

Event Type  Injury  

Manufacturer Narrative

Conclusion: review of the complaint file determined the unit was not returned because the customer discarded the device, so unable to confirm the complaint and unable to determine root cause for the issue with no product returned.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of this bio-console and external motor drive instrument the customer heard a noise and thought the ap40 pump decoupled.The external motor drive was on, but there was no forward flow.The nurses were hand cranking when the perfusionist arrived.The instrument was changed out with a backup and there was no resulting adverse patient effect.

• Brand Name: AFFINITY CP CENTRIFUGAL BLOOD 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12679678
• MDR Text Key: 277857285
• Report Number: 2184009-2021-00098
• Device Sequence Number: 1
• Product Code: DWE
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 09/24/2021
• 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