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

Model Number 16402

Device Problem Pumping Problem (3016)

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

Event Date 06/11/2014

Event Type  No Answer Provided  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the occlusion on the arterial roller pump was drifting.The customer hypoperfused the pt.The device was not changed out.After the case, the roller pump was moved to a vent pump.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the pt.Per the clinical review on 06/12/2014: the perfusionist (ccp) had some difficulty in setting the occlusion of the arterial pump during the set-up and priming stages of the cpb circuit, prior to cpb.The ccp experienced a few pump jams during priming and they felt the occlusion was "on the tighter" side.During cpb, the pt became acidotic (low arterial blood ph) and was hypotensive (low blood pressure).Sodium bicarbonate was administered, during cpb, to treat the acidosis.Roller occlusions were not adjusted during cpb.The surgical procedure was completed successfully without delay and without associated blood loss.The pt was weaned from cpb, without issue, and there was no harm observed or reported.After cpb, had been completed, the ccp checked the occlusion of the arterial roller pump and it was less (looser) than their normal practice.With the acidosis and hypotension during cpb, the clinical team believes that loose occlusion may have had an impact on the adequacy of blood flow.At this time, it is not clear if the looser than normal occlusion was due to a functional failure of the pump or due to use error in setting occlusion.

Manufacturer Narrative

Eval is in progress, but not yet concluded.

• 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: 3947778
• MDR Text Key: 4641825
• Report Number: 1828100-2014-00572
• 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: 06/12/2014

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?: Yes
• Date Returned to Manufacturer: 06/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2014
• Initial Date FDA Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention