MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYSTEM 8000; 8K (PUMP, ROLLER TYPE)

Model Number 16402

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2015

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the stop button on the cardioplegia roller pump was not working.The device was not changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the pt.Per the clinical summary on (b)(6) 2015: during cpb, the stop button of the cardioplegia pump lost functionality.Sarns 8000 roller pumps can be manually stopped via three different methods.They are: use the stop button; turn the speed knob to zero speed; and lift the cover of the pump.All of these methods will stop the rollers from rotating and will stop the delivery of cardioplegia solution.There is no mention of need for pump change out, as delivery of cardioplegia could be continued fro the procedure as the pump could be stopped with other methods.There is no indication the case was delayed and this issue should not lead to a delay in the procedure and would not lead to blood loss.There would be no error codes displayed with this type of event and the user would be able to continue using the pump.There was no report or indication of harm and no report that the case was not able to be successfully completed.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.The reported service representative (fsr) confirmed the reported issue.The fsr removed and replaced the roller pump with a loaner roller pump.Verification release test was completed.The unit operated to manufacturer specifications and was returned to clinical use.The suspect device was returned to the manufacturer for further evaluation.

Manufacturer Narrative

The reported complaint was confirmed.During the laboratory evaluation, the product surveillance technician (pst) observed poor connections on the membrane board which caused the stop button to not function.The pst powered on the roller pump and started rotations.When the stop button was pushed the pump guts continued to rotate and the light above the stop button did not illuminate.The pst measured the continuity between pins 4-11 and between pins p12 of j2, which are the connections to the top button and found the connections to be intermittent.The pst installed a membrane board from the 8k test platter into the pump and the stop button worked to stop the pump guts when pressed.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: TERUMO PERFUSION SYSTEM 8000
• Type of Device: 8K (PUMP, ROLLER TYPE)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 7346634145
• MDR Report Key: 4787319
• MDR Text Key: 5856249
• Report Number: 1828100-2015-00408
• 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 Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2015

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?: Yes
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 05/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/11/2015; 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2002
• 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