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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 UNIVERSAL ROLLER PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL ROLLER

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TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 UNIVERSAL ROLLER PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL ROLLER Back to Search Results
Model Number 16402
Device Problem Device Stops Intermittently (1599)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during use of the device for a cardiopulmonary bypass procedure, the roller pump stopped during the case. The device was not changed out, as the roller pump was able to be re-started and the case was completed successfully. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient. Per the clinical review on (b)(6) 2016: according to certified clinical perfusionist (ccp), during the weaning stage (end of cardiopulmonary bypass), the arterial roller pump stopped with a belt slip message posted on the pump. Ccp stated this pump has been behaving erratically the last few cases. Per ccp when the pump flow was below about 2. 5 l/min, the rotation of the pump was jerky. At higher speeds, the jerky issue was not observed. Per ccp the arterial flow rate during cpb was about 4. 5 l/min, and there were no issues observed at full flow. Near the end of cpb, during weaning, the flow was gradually reduced. Ccp stated the rotation became jerky at about 2. 5 l/min and the pump actually stopped with a belt slip message. There was no audible tone. Ccp re-started the pump with forward switches and in about 5 seconds the pump stopped again with a belt slip message. Ccp re-started the pump again and it stopped in about 5 seconds. This scenario was repeated, and the patient was able to be weaned from cpb. Ccp stated he considered hand cranking, but since the weaning process was quick there was no need to do that and weaning was successful. After the case, the pump was removed from service. The case was completed successfully, without delay and without associated blood loss. There was no harm observed.
 
Manufacturer Narrative
Evaluation is in progress, but not yet concluded.
 
Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) could not duplicate the reported complaint condition. No abnormal pump stoppage occurred. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
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Brand NameSARNS 8000 UNIVERSAL ROLLER PUMP
Type of DevicePUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL ROLLER
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
eileen dorsey
6200 jackson road
ann arbor, MI 48103
7347416074
MDR Report Key6203745
MDR Text Key63617905
Report Number1828100-2016-00815
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953901
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16402
Device Catalogue Number16402
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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