MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY PIXIE¿ CARDIOTOMY / VENOUS RESERVOIR WITH CARMEDA; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number CBP241

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Blood Loss (2597)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

Inspection of the returned pixie reservoir indicated the pressure relief valve cap was still installed, potentially contributing to poor drainage/lines popping off.Additional visual inspection showed no outward signs of any damage including the vent port or any assembly errors.Investigation is ongoing.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 when the patient went on bypass, the affinity pixie oxygenator/cvr drainage was very poor.One of the vent lines popped off the reservoir twice and caused blood loss.The volume of blood loss (ml) was not provided.The product was replaced.They came off bypass for about 3 minutes to change out reservoir.Cpr was needed at this time.The customer stated the only known patient impact was blood loss, patient status or other details were not provided.The replacement reservoir was used to complete the case.

Manufacturer Narrative

Investigation conclusion: complaint is not confirmed for the pixie oxygenator/cvr's poor drainage.Review of this unit's device history record found no abnormalities or ncmrs initiated during manufacturing that would cause or contribute to the reported event.The returned device pressure relief valve cap was still installed.The product ifu instructs the user to remove the obturator cap from the cvr positive/negative pressure relief valve and to ensure the cvr is vented to the atmosphere by removing the vent port cap during setup.Using the cvr without removing the obturator cap can contribute to poor drainage and vent lines popping off.Root cause is undetermined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AFFINITY PIXIE¿ CARDIOTOMY / VENOUS RESERVOIR WITH CARMEDA
• Type of Device: OXYGENATOR, 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8216338
• MDR Text Key: 132038685
• Report Number: 2184009-2019-00002
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: CBP241
• Device Catalogue Number: CBP241
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2017
• 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