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

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

(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.

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.

• Brand Name: LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, 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 Key: 6213899
• MDR Text Key: 63722246
• Report Number: 1828100-2016-00830
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: UP
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/27/2017
• Supplement Dates FDA Received: 01/27/2017; 03/17/2017; 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1