Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY CP CENTRIFUGAL PUMP; TUBING, PUMP, CARDIOPULMONARY BYPASS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PERFUSION SYSTEMS AFFINITY CP CENTRIFUGAL PUMP; TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Model Number CBAP40
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluation has begun.Investigation is ongoing and conclusion will be provided following completion.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use of two cbap40 pumps it was noted that the flow dropped from 4.0 l/min to 0.8 l/min.The customer could not regain original flows despite increased rpm¿s and manipulation of cannulae.The patient was put on a cardiohelp as a result.It was requested but unknown if there was any adverse effect to the patient as a result of this issue.
 
Manufacturer Narrative
Visual analysis: upon receipt at medtronic¿s quality laboratory, visual inspection showed no outward signs of any damage.Performance analysis: the device was tested per specification.The device was run on a bio console from 0-4000 rpm¿s, us ing fluid.The noise level recorded during the analysis was less than 60 decibels, the specification is less than 68 db.The device was set to flow at 7 lpm for 10 min with no issues observed.From the returned device, unable to determine the cause of the issue the user noted.Device worked as designed.There was no patient adverse effects, will continue to monitor for any trends.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 two cbap40 pumps it was noted that the flow dropped from 4.0 l/min to 0.8 l/min.The customer could not regain original flows despite increased rpm¿s and manipulation of the cannulas.The patient was put on a cardiohelp as a result.It was requested but unknown if there was any adverse effect to the patient as a result of this issue.The perfusion record will not be made available to medtronic.The priming solution consisted of plasmalyte a, 12.5 g albumin and 50 meq of nahco3.These devices were part of a custom tubing pack.Model number: cb7f11r9 lot number: 217507396.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key8930472
MDR Text Key155505691
Report Number2184009-2019-00052
Device Sequence Number1
Product Code DWE
Combination Product (y/n)N
PMA/PMN Number
K132712
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/09/2021
Device Model NumberCBAP40
Device Catalogue NumberCBAP40
Device Lot Number217443372
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2019
Date Manufacturer Received11/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-