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

Model Number CBAP40

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

The product has not been returned for analysis and no definitive conclusions can be made regarding the root cause of the clinical observation.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 this centrifugal pump decoupled.The customer stated that the rpms exceeded 4000 during long term use.Customer stated they were aware that the ifus recommend flow of 4000 rpms and below, but in this situations, the patient required a higher rpm due to a combination of size and metabolic demand, in conjunction with a small cannula size.Customer reported noticing the blood pressure was dropping and the flow was diminished.The bio-console handcrank was used and forward flow was achieved.The bio-console instrument was changed out with a backup.The rpm was turned up to 4200 using the same centrifugal pump and the situation repeated.The handcrank was used again, the centrifugal pump was replaced and blood flow re-established.Rpms were kept under 4000 and no further issues were noted.There was no resulting adverse patient effect.

Manufacturer Narrative

Correction; brand name: affinity cp centrifugal pump.Product code: dwe, model: cbap40, lot#: unknown, udi: asku.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AFFINITY CP CENTRIFUGAL 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7581572
• MDR Text Key: 110446967
• Report Number: 2184009-2018-00013
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CBAP40
• Device Catalogue Number: CBAP40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• 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
• Patient Outcome(s): Required Intervention