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

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.

• Brand Name: SARNS 8000 UNIVERSAL ROLLER PUMP
• Type of Device: PUMP, 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 Key: 6203745
• MDR Text Key: 63617905
• Report Number: 1828100-2016-00815
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2017

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: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/27/2017; 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2006
• 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