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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1 PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP FOR APS 1

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TERUMO CARDIOVASCULAR SYSTEMS CORP. LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1 PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP FOR APS 1 Back to Search Results
Model Number 816571
Device Problem Device Stops Intermittently (1599)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2016
Event Type  malfunction  
Manufacturer Narrative
The reported complaint was not verifiable. No preventive maintenance (pm) documentation can be provided by the distributor. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Manufacturer Narrative
(b)(4). Per subsidiary employee, during visit to the user facility, it was found out that the machine especially the pump was in bad condition. The pump showed among others mechanical issues: visible strong wobbling of the pump guts, noticeable vibration on the bottom pump housing and audible running noises.
 
Event Description
It was reported that during use of the device for a cardiopulmonary bypass procedure, the pump stopped. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.
 
Event Description
As per clinical review on 04-jan-2017: the large roller pump was being used as the arterial pump and it stopped during cardiopulmonary bypass (cpb). It was not clear if any messaging was posted on the pump when the stop(s) occurred. The pump was re-started immediately after the stops by pressing the start button on the local display. The manufacturer's subsidiary employee inspected the pump and noticed that the pump was noisy, there was noticeable vibration and the roller mechanism wobbled. The pump was not being regularly maintained and there was no preventive maintenance being done on the pump or the entire system. The case was completed successfully, without delay and without associated blood loss. The pump was used for the entire procedure with no changed out required. There was no harm observed.
 
Manufacturer Narrative
Per data log analysis, on (b)(6) 2016 a perfusion screen is opened at 8:10:45 am. At 9:34:05 am the arterial large roller pump is started. At 9:34:41 am, speed is set to 0 and the pump is stopped. At 10:00:29 am the pump is started. At 1:51:37 pm speed is set to 0 and the pump is stopped. The pump is started at 1:51:47 pm and stopped at 1:53:35 pm. At 3:44:10 pm, the central control monitor (ccm) reports the pump missing and at 5:01:11 pm the pump is detected again by the ccm. At 5:01:17 pm the perfusion screen is exited. There is no way to tell from the log if the pump was disconnected or went missing on its own. There were no errors associated with the pump stops that did occur.
 
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Brand NameLARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
Type of DevicePUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP FOR APS 1
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 Key6213899
MDR Text Key196703939
Report Number1828100-2016-00830
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUP
PMA/PMN Number
K022947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number816571
Device Catalogue Number816571
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2010
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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