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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY CP CENTRIFUGAL PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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PERFUSION SYSTEMS AFFINITY CP CENTRIFUGAL PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE Back to Search Results
Model Number CBAP40
Device Problems No Flow (2991); Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2021
Event Type  Injury  
Manufacturer Narrative
Initial complaint device analysis: upon receipt at medtronic¿s quality laboratory, visual inspection showed signs of clotting in the device.Additional visual inspection showed the impeller was loose inside the housing with damage observed to the upper pivot.The noise level from the device was greater than 80 decibels, as compared to the specification of 68 decibels.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use of a cbap40 affinity cp centrifugal blood pump, the clinicians observed a "rattling" noise.Patient was stable.The team decided to changeout the 560 drive motor, but continue to support the patient with the ap-40 disposable.The rattling noise continued.The team decided it was best to consider changeout of the pump head.As they prepared to changeout, they lost flow.The team tried to handcrank as the entire circuit was changed.It was asked but is unknown whether there was any impact to the patient associated with this event.
 
Manufacturer Narrative
Medtronic assessment and conclusion: upon receipt at medtronic¿s quality laboratory, visual inspection showed signs of clotting in the device.Additional visual inspection showed the impeller was loose inside the housing with damage observed to the upper pivot.The device was run with a bio console instrument from 0-4000 rpm¿s.The noise level recorded during the analysis was greater than 80 decibels, compared to the specification of 68 decibels.Additional information received revealed the type of clinical procedure was for status post covid-19 and the pump was used for 18 days at the time of the event.Per supplemental ifu, extended use was deemed to not produce undue risk.There were no patient adverse effects.Trends for issues with this product are reviewed at quarterly quality meetings.If additional information is received, the investigation will be reopened if deemed necessary.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use of a cbap40 affinity cp centrifugal blood pump, the clinicians observed a "rattling" noise.Patient was stable.The team decided to changeout the 560 drive motor, but continue to support the patient with the ap-40 disposable.The rattling noise continued.The team decided it was best to consider changeout of the pump head.As they prepared to changeout, they lost flow.The team tried to handcrank as the entire circuit was changed.It was asked but is unknown whether there was any impact to the patient associated with this event.Additional information: the hand crank was used to maintain flow for 10 to 15 minutes while the external motor drive was switched out.The bio-console base, external motor drive and centrifugal pump had been in use for 18 days when the reported issue occurred.The procedure was a s/p covid.The customer has declined service for the bio-console based and external motor drive as perfusion ran the instrument with a new disposable circuit and they could not replicate the issue.
 
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Brand Name
AFFINITY CP CENTRIFUGAL PUMP
Type of Device
PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Manufacturer (Section D)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
MDR Report Key11706441
MDR Text Key261809866
Report Number2184009-2021-00023
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
PMA/PMN Number
K191077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCBAP40
Device Catalogue NumberCBAP40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2021
Date Manufacturer Received04/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age20 YR
Patient Weight70
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