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 Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) sent the customer an email on research done on artifacts in the operating room (o/r).The customer will test and if further service needed they will call back.The customer contacted the fsr, they would like system checked out.The fsr could not duplicate the reported complaint.The roller pump passed release testing successfully.Corrective maintenance/inspection completed successfully.The unit operated to manufacturer specifications and was returned to clinical use.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the roller pump was generating a charge and the ge monitor was picking up these artifacts.The device was not changed out, as they continued to use.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical summary dated (b)(6) 2016: this is a known phenomenon with all roller pumps.As roller pumps squeeze plastic tubing, a piezoelectric charge is generated and this charge can be transmitted in the perfusion circuit to the patient.This charge travels in the fluid path of the tubing circuit and can appear as interference of the electrocardiogram (ekg) waveform.This has been widely published and discussed in the literature, and this has not been attributed to any harm of the patient.It is a nuisance though, as it does cause interference in the ekg tracings of the patient.It is sometime due to poor or dry ekg electrodes and/or poor technique in preparing the skin prior to ekg pad placement.Some clinicians have been able to minimize the interference by applying lubricant to the tubing in the pump raceway or by changing ecg leads and / or electrodes.Ecg interference has no impact on the ability of the pump or perfusion system to provide indicated functionality.

• 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: 5849773
• MDR Text Key: 51372770
• Report Number: 1828100-2016-00537
• 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
• Report Date: 08/05/2016

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2004
• 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