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

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLANDS5 ROLLER PUMPCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

SORIN GROUP DEUTSCHLAND S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS   Back to Search Results
Model Number 10-80-00
Device Problem Pumping stopped
Event Date 08/13/2012
Event Type  Other  
Manufacturer Narrative

Patient identifier and age was not provided. Sorin group (b)(4) manufactures the s5 roller pump. The incident occurred in (b)(6). This medwatch report is filed on behalf of sorin group (b)(4). Sorin group received a report that during a procedure, the s5 roller pump stopped with no error messages. The perfusionist hand cranked the pump to maintain blood flow for the remainder of the procedure. Sorin received information from the perfusionist that the patient is fine. A sorin group field service representative was dispatch to the facility to evaluate the issue. The pump was run for two hours with no issues. The bubble and pressure controls were tested and no problems were found. The service representative then ran the pump overnight and found the pump to be working properly with no deviations or issues. After discussion with the perfusionist, it was determined the pump stop was most likely caused by the pump cover being opened. Retraining was implemented. No further action is necessary.

 
Event Description

Sorin group received a report that during a procedure, the s5 roller pump stopped with no error messages. The perfusionist hand cranked the pump to maintain blood flow for the remainder of the procedure. There was no patient.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameS5 ROLLER PUMP
Type of DeviceCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section F)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich
GERMANY D 80939
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich
GERMANY D 80939
Manufacturer (Section G)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich
GERMANY D 80939
Manufacturer Contact
cheri voorhees, manager
14401 west 65th way
arvada , CO 80004
(303) 467 -6527
Device Event Key2786992
MDR Report Key2753778
Event Key2650393
Report Number1718850-2012-00970
Device Sequence Number1
Product CodeDTQ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 08/13/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/12/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number10-80-00
Device Catalogue NumberBA
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received08/13/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/12/2012 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
-
-