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

Model Number 16402

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) confirmed the tongue was broken and replaced it with a new one.The unit operated to the manufacturer's specifications.The suspect part will be returned to the manufacturer.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the tongue on the roller pump was broken.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.On the date of (b)(6) 2017 the perfusion team noticed during set up for the case that day that the sucker pump had a broken tongue on its occlusion mechanism.The tongue is needed for occlusion of the roller pump.The team used another roller pump as a sucker for they use a heart lung machine (hlm) base that has an extra roller pump not in use.This issue was easily and timely mitigated, for they had the time to load the sucker tubing in the available roller pump.This incident did not delay the surgical procedure, for it was mitigated prior to the start of the surgical procedure.There was no blood loss, nor harm.

Manufacturer Narrative

The reported complaint was confirmed.The product surveillance technician (pst) visually verified that the tongue was broken.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 CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7137500
• MDR Text Key: 95742885
• Report Number: 1828100-2017-00593
• 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: 02/22/2018

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: 01/29/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 02/21/2018
• Supplement Dates FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2001
• 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