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

Model Number CBAP40

Device Problems Restricted Flow rate (1248); Infusion or Flow Problem (2964); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

Failure to follow instructions: device is indicated for use up to 6 hours.This device had been used for 5-7 days.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of this centrifugal pump it experienced a loss in flow after 5-7 days.The icu nurse heard a loud grinding noise, and the flow dropped from 4 lpm to less than 0.5 lpm.The nurse began handcranking, and was able to resume flow.The perfusionist came and switched to a back-up driver and was able to resume flow, but the same grinding noise continued.At that point, the ap40 was replaced with a backup.Use of the instrument was continued with no adverse patient effect.The patient was taken off of extra corporeal membrane oxygenation (ecmo) the following day, after 6-8 days on ecmo.The perfusionist saw a white ring on the inside of the disposable, where they believe the motor was rubbing against the inside cone.

Manufacturer Narrative

Additional information: the customer stated that there seemed to be a clot in the ap40.The crystalloid prime was used.The customer stated that the rotor of the ap40 was off centre.Investigation: the unit was not returned as the customer discarded the device.Unable to confirm complaint or determine root cause with no product returned.It is noted the device was in use for greater then 7 days.There were no patient adverse effects.Medtronic will continue to monitor for similar future events.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7694499
• MDR Text Key: 114199155
• Report Number: 2184009-2018-00021
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132712
• 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,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• 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: 08/08/2018
• 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