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

Model Number 16402

Device Problem Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The user facility's biomed is a terumo trained personnel and will try to repair the pump.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the knob stops when turning at 15 rpm.The product was not changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review, the pump was being used as a vent pump and when the speed was increased to or past 15 rpm or decreased down towards 15 rpm, the pump would hesitate but the speed knob could be increased or decreased and the pump speed would change after the hesitation.The pump was able to be used to complete the procedure.The pump was removed from service after the case was completed.The case was completed successfully, without delay and without associated blood loss.It was not changed out during the actual procedure.There was no harm observed.

Manufacturer Narrative

The reported complaint was not verifiable.Per the user facility biomedical (biomed) employee, the assigned biomed for this complaint was on leave and they cannot access the order confirmation number.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: SARNS 8000 UNIVERSAL ROLLER PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE¿SARNS 8000 UNIVERSAL ROLLER PUM
• 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: 6215546
• MDR Text Key: 63824617
• Report Number: 1828100-2016-00834
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/1999
• 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