MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP. SARNS CENTRIFUGAL SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM

Model Number 801046

Device Problem Pumping Problem (3016)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The fsr could not verify any issues with the centrifugal controller unit.He downloaded logs and tested the unit.The fsr could not determine any issues.The fsr spoke to the ccp about the case, another ccp was pumping case and about 30 minutes into bypass when the recirculation line off of oxygenator "y" became disconnected.The ccp came off bypass for about 30 seconds while reconnecting and clearing air.The staff estimated 500cc blood loss onto floor.Shortly after correcting the cpg line became disconnected, the ccp reconnected.Neither disconnect caused any patient issues and the case was completed successfully.The unit operated to manufacturer specifications and was returned to clinical use.Per data log analysis there were no over pressure alarms in the log.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure (cpb), the tubing was popping off the centrifugal controller unit.The device was not changed out.The event resulted in a delay of the surgical procedure and there was blood loss of 500cc.There were no reported adverse consequences to the patient.The user facility requested the field service representative (fsr) to check out the system.Per clinical summary on (b)(6) 2016: this complaint is related to two separate perfusion circuit tubing separations that occurred during cpb.The two separations were in different locations of the cpb circuit and these tubing connections were both performed manually by the perfusionist (ccp) during set-up of the circuit prior to the case.These manual connections were not tie-banded.A centrifugal pump was being used as the arterial pump and this type of pump is pressure sensitive to changes in resistance and they are not able to generate high levels of pressure.Because of the tubing separations during cpb, local fsr was asked to check out this system-1 for any issues with the entire system and/or the centrifugal part of the system.No issues were found during this check that would lead to speed or pressure changes without user control.No malfunctions were found and the system continues to be used.

Manufacturer Narrative

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 CENTRIFUGAL SYSTEM
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 5970099
• MDR Text Key: 55697437
• Report Number: 1828100-2016-00636
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950739
• 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: 12/30/2016

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: 801046
• Device Catalogue Number: 801046
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 09/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2006
• 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
• Treatment: OXYGENATOR; TERUMO TUBING PACKS