MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 PERFUSION SYSTEM; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS ROLLER PUMP

Model Number 16402

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.Per the user facility¿s biomedical engineer (biomed) this is a spare pump, not used regularly.Sits on the base in the back-up position.He feels there is a dead spot in the potentiometer.The biomed is calling the manufacturer technical support on the possible cause/repair.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the rotation of the roller pump was hesitating as speed was varied.The device was not changed out.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) 2015: during cardiopulmonary bypass, the roller pump was being used in the vent position when he noticed that the rotation was hesitant as the speed was varied.The roller pump was not changed out, varying the speed controller would allow it to operate.The perfusionist (ccp) stated that during setup the occlusion was performed in the usual way, occluding the inlet side of the roller with the tubing clamp.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory evaluation, the product surveillance technician (pst) installed the cable assembly onto an 8k pump test fixture.Started rotations of the test fixture pump and slowly turned the speed knob to increase speed.At approximately 100 revolutions per minute (rpms), the pump hesitated for a moment then resumed rotating.No physical anomalies with the assembly were found.The product will be sent to service to be brought to manufacturers specifications before being returned to the customer.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 PERFUSION SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS ROLLER PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5225351
• MDR Text Key: 31574873
• Report Number: 1828100-2015-00966
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2015

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: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2006
• 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