• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

  • 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
 

THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE Back to Search Results
Model Number 102953
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Sepsis (2067)
Event Date 03/02/2020
Event Type  Injury  
Manufacturer Narrative
Serial number of pump was requested but not provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported that the patient initially presented with cardiogenic shock that required ecmo (extracorporeal membrane oxygenation).The patient had a heartmate 3 implanted on (b)(6) 2020 and the rvad (right ventricular assist device) centrimag explanted on (b)(6) 2020.The patient had a prolonged hospital course complicated by ventilator-dependent respiratory failure status post tracheostomy on (b)(6) 2020.The patient had clostridium difficile right groin hematoma status post washout and sartorius flap on (b)(6) 2020.The patient was transferred back to the critical care unit (ccu) on (b)(6) 2020 due to altered mental status with concern for sepsis.The patient had sacral decubitus ulcers status post diverting loop sigmoid colostomy, gastrostomy-jejunostomy (gj) tube, and profound lower extremity weakness likely due to spinal infarct status (b)(6)2020.The patient had anuric renal failure on intermittent hemodialysis (ihd) and septic shock due to proteus bacteremia/(b)(6)/coagulase-(b)(6) (b)(6) on (b)(6) 2020.The patient had many episodes of bacteremia throughout hospitalization, one source was right groin clostridium difficile pneumonia.It was not known if it was device related.The treatment was iv (intravenous) antibiotics and wash-outs with irrigations/debridement.The patient had a hemorrhagic shock in the status post gastrointestinal bleeding that was complicated by acute hypoxemic/hypercarbic respiratory failure post tracheostomy exchange on (b)(6) 2020.The patient had ventilator-associated pneumonia post antibiotics and was transferred back to cardiac intensive care unit (cicu).Manufacturer report number of heartmate pump: 2916596-2021-00079.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between the reported events and the centrimag device, (b)(6), could not be determined through this evaluation.Additionally, a specific cause for the reported infection could not be determined.It was reported under mfr # 2916596-2020-06542 that the centrimag blood pump was explanted on (b)(6) 2020.Multiple requests for additional information, including the disposition/return status of the device, were sent to the customer; however, no response has been received at this time.The us centrimag blood instructions for use (ifu) lists bleeding and infection as adverse events that may be associated with the centrimag circulatory support system.Review of the device history record (dhr) for the centrimag blood pump (dhr cm pump (b)(6)) revealed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) lists bleeding and infection as adverse events that may be associated with the centrimag circulatory support system under ¿adverse events¿.This ifu also provides the following warnings and cautions: ifu warning #7: it is intended that systemic anticoagulation be utilized while this device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Ifu warning #10: frequent patient and device monitoring is recommended.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.No further information was provided.The manufacturer is closing the file on this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CENTRIMAG BLOOD PUMP
Type of Device
PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ  CH-8005
MDR Report Key11179807
MDR Text Key229155759
Report Number3003306248-2021-00007
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
PMA/PMN Number
K020271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/07/2021
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? No
Device Operator Health Professional
Device Expiration Date06/30/2021
Device Model Number102953
Device Catalogue Number102953
Device Lot NumberL05792-LA1
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/17/2020
Initial Date FDA Received01/15/2021
Supplement Dates Manufacturer Received05/28/2021
Supplement Dates FDA Received06/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
HEARTMATE 3 LVAS IMPLANT KIT
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age52 YR
Patient Weight101
-
-