MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 801763

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Data log analysis: 03-oct-2017.The logs show many modules / pumps reporting 5v supply voltage test failures.Data transfer rs-232; large roller (b)(4); large roller (b)(4); large roller (b)(4); temperature (b)(4); temperature (b)(4).If all of these are on the same nic then the possible causes are the power manager, power cable from power manager to the nic, or the nic.The power manager did not log any issues with 5v so i would suspect the cable 1st, power manager 2nd, nic 3rd.As per the field service representative (fsr) while troubleshooting the reported complaint he confirmed there were red x's on three of the roller pump icons on the ccm.The left side nic power cable was replaced.The unit operated to manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, an unidentified alarm intermittently went off without displaying an error message.The cardioplegia (cpg) and vent i and ii turned off after the unit alarmed.The temperature probe module was occasionally blinking red.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: on (b)(6) 2017, during a bypass procedure, according to the perfusionist the advanced perfusion system 1 (aps1) had "an unidentified alarm going off intermittently, with no messages on the central control monitor (ccm).Occasionally the cardioplegia (cpg) roller head and two vent roller heads would turn off after an alarm.The perfusionist recalled seeing a red x on the cpg pump.The vent and the cpg pump, per the second perfusionist, stated after they would turn off, they could turn the pumps back on without issue.The temperature module light was also flashing red.All modules and pumps affected were located on the left side of the unit.The perfusionist did not change out any component on bypass, but the aps1 was taken out of service after the case.The perfusion team felt it was safer for the patient to proceed without changing out components.The incident did not delay the surgical procedure, and the patient was weaned from cpb without issue.There was no blood loss, and no harm was observed.In consulting with a manufacturer associate regarding the log data it revealed that the log showed 5v errors on several pumps and modules.This is an indication of a problem with the power manager, the cable that connects the power manager to the network interface card (nic) or the nic itself.The manufacturer stated the most likely cause is a cable issue.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) tested the red wire of the device under test (dut) cable was tested for connection end to end.Resistance testing showed no intermittency in the 5 volts direct current (vdc) conductor with maximum resistance remaining below ½ ohm (0.39 ohms) which is a typical value.The pst assigned the roller pumps and the modules to a perfusion screen and began rotation at 1lpm tested for three hours with no problems observed.Then the pst increased the pump speed to 2lpm and increased tubing occlusion of both pumps by 15 clicks, no problems were observed during additional three hour period.The pst stopped the pump rotation but left the system powered up for 16 hours overnight.The pst restarted the pump rotation with the same speeds used and manipulated the network interface card (nic) cable occasionally over three hour period.The pst then added one large roller pump, fully occludded, increased occlusion, manupulated nic cable and observed no problems.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: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• 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: 6913902
• MDR Text Key: 89933860
• Report Number: 1828100-2017-00448
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153376
• 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: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2006
• 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