MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP

Model Number 816571

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the occlusion backed off and the perfusionist had to manually occlude the pump.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Pre clinical review: per the customer, during a procedure the perfusionist (ccp) was in the process of going down on flow for cross-clamp placement.While he was going up to release the vacuum, he accidently hit the arterial roller head with his wrist.The movement knocked the occlusion cap off and he heard a zip sound, and lost all occlusion in the arterial 6 inch roller head.(preventive maintenance (pm) had just been done the day prior on this pump) when the ccp came back up on flow from going down on flow for cross-clamp placement, he stated that is was very obvious that he had lost all occlusion on the arterial head.He proceeded to quickly reocclude the arterial head, and stated that the patient's blood pressure was low for approximately 10 seconds.He noted that he was able to re-occlude the head without issue, but he may have over-occluded it at that moment, because of his need to quickly get back to a normal flow for the patient.He was able to flow at set occlusion and flow the remainder of the procedure.He also did say there was no apparent hemolysis of the red cells due to the nature that his re-occlusion may have been tighter than previously set.The incident did not delay the continuation of the surgical procedure, and the patient was weaned from bypass without issue.There was no blood loss nor any harm observed.

Manufacturer Narrative

The reported complaint was not confirmed.No evaluation was done on this device.The customer did not return the unit to the manufacturer.They continue to use the device with no further incidents.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: LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6961234
• MDR Text Key: 90685850
• Report Number: 1828100-2017-00479
• 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
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2008
• 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