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

Model Number 16402

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the roller pump was not providing suction.The customer changed out a one-way valve, which did not fix the issue.As a result, an alternate roller pump was employed.The surgical procedure was completed successfully.There was no delay in case, no blood loss, nor adverse consequences to the pt.Per the clinical review on (b)(6) 2014: the reported issue is there were intermittent issues during the procedure in providing adequate suction of blood from the surgical field.A sarns 8000 roller pump was used for suction and the tubing assembly had a negative pressure relief valve (medtronic pack) that was used to limit the amount of negative pressure able to be applied.The perfusionist (ccp) stated she had no issue setting the occlusion of the pump during set-up and priming and there were no messages posted on the pump (e.G.Pump jam or beltslip) any time during the procedure.A few times during cpb, the cv surgeon stated that suction was not adequate.The ccp checked the occlusion of the roller pump and it was adequate.She then removed the one-way pressure relief valve in the suction tubing and the quality of suction removal was not improved.The ccp elected to change out the suction roller pump on the base.A roller pump was removed from an un-used sarns 8000 base and was brought to the operating room (o.R.).The tubing was removed from the pump and the sucker pump was un-plugged and removed from the base.The replacement pump was placed on the base and plugged-in.The sucker tubing was placed in this pump and the occlusion was checked.Suction, with this new pump, was started and used from the remainder of the procedure.While the pump was changed out, the cell saver suction was used so as not to delay the procedure.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

This complaint is related to mdr # 1828100-2014-01109.Per the ccp, this issue happened a couple of months ago in (b)(6) 2014, exact date is unk.The field service representative (fsr) checked the condition of bearings and rollers, all in excellent condition and free moving.The fsr checked the roller to roller setting which was within the (b)(4) limitation.As a precaution, the fsr swapped out serial number (b)(4) position one pump with serial number (b)(4) position four pump.Each pump performed to mfr specifications and was returned to clinical use.

• 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: 4366165
• MDR Text Key: 5266969
• Report Number: 1828100-2014-01108
• 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: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2007
• 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
• Treatment: MEDTRONIC TUBING PACK