MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYSTEM 8000; 8K

Model Number 16413

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2014

Event Type  malfunction  

Event Description

It was reported that during pre-cardiopulmonary bypass of the device for a cardiopulmonary bypass (cpb) procedure, the aortic pressure reading on the arterial monitor was 30mmhg.That's 20 points lower than on electrocardiogram (ecg).The device was not changed out, as the surgeon took the cannulae away from the arterial line, recannulated and still had the same pressure reading of 30mmhg.The customer changed out the cable and still had issue.The attempts to change out components delayed the start of the case by approximately ten minutes.The surgical procedure was completed successfully.There was no blood loss, nor adverse consequences to the pt.Per the clinical review on (b)(6) 2014: the customer used a sarns 8000 perfusion system with cpb circuit disposable products from medtronic.Disposable pressure transducers were used with the arterial monitor and pt monitor and they were labeled from icu medical, inc of san clemente, ca.After the aortic cannula (pre-cardiopulmonary bypass) was placed, the arterial blood pressure of the pt (monitored on anesthesia bedside monitor) was compared to the cpb arterial line pressure that is measured on the 8000 safety monitor.Usually, these two pressures are very close, but in this case the pressure on the safety monitor was 20-25 mmhg lower than the pt arterial pressure.The cardiovascular (cv) surgeon elected to disconnect the arterial line tubing from the aortic cannula in order to verify the correct placement of the arterial cannula.The cannula and tubing were debubbled and re-connected and the pressure measurement on the safety monitor continued to be 20-25 mmgh lower than the pt arterial pressure.The pressure transducer and cable (connected to the safety monitor) were changed out and no improvement was observed.The team elected to initiate cpb and the delay to start cpb was about ten minutes as the troubleshooting of the events took place.The pt was stable hemodynamically during these troubleshooting steps.According to the ccp, the cpb arterial line circuit pressure (measured on the safety monitor) seemed appropriate for the blood flows and pt pressure conditions.There were no issues observed during cpb.The case was completed successfully, without associated blood loss and a delay of ten minutes was experienced.There was no harm observed.

Manufacturer Narrative

This complaint is related to mdr # 1828100-2014-01106.The pressure transducer and cable (attached to the arterial monitor) were changed out, these are not mfr products.The field service representative (fsr) used a simulator transducer to check pressure values.All pressures from 0 to 500 on the simulator were all on target.Temperatures were also on target.The ccp stated that they had switched disposable transducer cable mfr a couple months ago.The fsr and ccp talked with clinical services and are wondering whether the disposable cables could have a bad batch.Also suggested the ccp try the unused part of the cardioplegia (cpg) monitor and check the reading of pressures.The arterial monitor performed to mfr specifications and was returned to clinical use.

• Brand Name: TERUMO PERFUSION SYSTEM 8000
• Type of Device: 8K
• 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: 4366127
• MDR Text Key: 5288405
• Report Number: 1828100-2014-01107
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915183
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16413
• Device Catalogue Number: 16413
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 12/22/2014
• 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: AND CABLES; ICU MEDICAL DISPOSABLE PRESSURE TRANSDUCERS