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 Problems Device Emits Odor (1425); Smoking (1585); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2018

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the end user heard a popping noise and smelled like an electrical smoke.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) found the returned power supply had no direct current (dc) output voltage.The 'power good' output signal was at zero volts, typical is 200 millivolts (mv).

Event Description

The heart lung machine (hlm) was used for a cardiopulmonary (cpb) procedure on (b)(6) 2018.The team turned the unit on and prepared for cpb without issue.In the middle of the procedure the perfusionist heard a popping noise and she stated she smelled what appeared to be electrical smoke.In conjunction, the hlm gave her a message on the central control monitor (ccm) that the battery could not be fully charged and that backup may not be available.She continued the case without the loss of alternating current (a/c) power, therefore had no functional failure affecting patient perfusion.The field service representative (fsr) was able to troubleshoot the machine shortly after the incident and found that the power supply on the base had failed.The incident did not delay the surgical procedure, for she was on ac power the entire case.There was no blood loss or harm associated with the event.

• 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
• MDR Report Key: 7764565
• MDR Text Key: 116542970
• Report Number: 1828100-2018-00413
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K163531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• 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: 08/21/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1