MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1

Model Number 801041

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.Per follow-up with the ccp, she was unable to correct the occlusion, there was no occlusion per pressure transducer even when the pump jammed, and they changed out the pump before patient came to room.Tubing being used was pvc 4:1 special cardioplegia; revolutions per minute (rpm) /flow rate was set at 200-300 cc/minute.The new pump was fine with occlusion and pressure testing.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the cardioplegia (cpg) roller pump could not be occluded.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.

Manufacturer Narrative

(b)(4).During the laboratory evaluation, the product surveillance technician (pst) could not duplicate the reported complaint.The pst observed the pump pressure and occlusion to pass testing and meet specifications.Visual inspection showed no signs of damage.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

The service repair technician (srt) performed functional test and observed the customer's pump to operate as intended.The srt observed proper occlusion during service investigation.Performed rate of fall test and customer pump occluded as intended.The srt performed preventive maintenance and verification / release test.The roller pump operated to the manufacturer's specifications.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 ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1
• 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: 5320150
• MDR Text Key: 34571507
• Report Number: 1828100-2015-01057
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131618
• 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,Followup,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801041
• Device Catalogue Number: 801041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2003
• 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