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

Model Number 16402

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2014

Event Type  No Answer Provided  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the perfusionist (ccp) said that the roller pump head started to "whine" half way through the pump run.As time went on, the roller pump started to make a "grinding" type sound.Additionally, the pump head started to pulse, without the pulsation being activated.The ccp did test the arterial pump head after removing the tubing, and it did function without the hesitation or whining.It appeared to have happened while it was under pressure.The ccp did know that the occlusions were checked prior to cpb, and they appeared to be set properly.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.Clinical review on (b)(4) 2014: during setup of the cpb circuit, the perfusionist (ccp) noticed that when the roller occlusion was checked and adjusted for ths pump (arterial pump), one roller seemed tighter than the other (very small drop in pressure compared to the other roller).About sixty minutes into cpb, the ccp noticed a squeak and clicking sound from the roller pump.About fifteen minutes later, the sound was more of a "thumping sound".In another fifteen minutes, or so, the sound was more of a "rumbling growl" sound.Up to this point, the pump speed or resultant flow was not impacted.During weaning of the patient from cpb, when the pump speed was reduced and the flow provided was about 2 liters/minute, the ccp noticed a pulse-like behavior of the roller pump.The pump was still functioning and the patient was able to be successfully weaned from cpb.Cpb was terminated and the patient had no clinical issues as a result of the pump noise or behavior.The case was completed successfully, without delay and without associated blood loss.There was no harm of the patient observed or reported.After the procedure, the entire heart-lung machine was removed from service.

• Brand Name: TERUMO PERFUSION SYSTEM 8000
• Type of Device: 8K (PUMP, ROLLER TYPE)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3941772
• MDR Text Key: 16181141
• Report Number: 1828100-2014-00539
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2014

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: 06/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2014
• Initial Date FDA Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2001
• 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