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

Model Number 16402

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2015

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the perfusion system worked fine but some remember a strange noise which seemed to come from the machine.At the same time or soon after the noise, one of the roller pumps failed to maintain occlusion on the circuit.The occlusion was hand adjusted until a pump jam alert was alarmed and then the occlusion was backed-off to allow flow.Flow through the circuit was never re-established.There was a 12 minute delay and 2000ml of blood loss.As a result, an alternate system-1 perfusion system was employed.The surgical procedure was completed successfully.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.The field service representative (fsr) sent a loaner replacement roller pump ((b)(4)).

Manufacturer Narrative

The reported complaint was not confirmed.During the laboratory evaluation, the product surveillance technician (pst) observed no strange noises or failure of occlusion occurred on the roller pump.The pump was received with the occlusion knob turned within a half a turn of full occlusion.The pst inserted tubing into the pump's raceway and started rotations.No strange noises were heard from the pump.The pst increased occlusion until pump jam occurred.The pst removed the pump from its housing and observed the rotation of the motor, belt and guts pulley with nothing unusual seen or heard.The pst operated the pump for three days with no strange noises or changes in occlusion occurring.There was no physical or visual indication of failure.The roller pump was sent to service and the service repair technician (srt) observed the customer pump to operate as intended during functional testing.The srt replaced the roller pump central processing unit (cpu) board and the membrane panel as a precautionary measure.The unit operated to manufacturer specifications and will be 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 ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4791502
• MDR Text Key: 5799827
• Report Number: 1828100-2015-00419
• 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
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 05/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2015
• Initial Date FDA Received: 05/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• 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
• Patient Outcome(s): Life Threatening; Required Intervention