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

Model Number 801188

Device Problems Calibration Problem (2890); Output Problem (3005)

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

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) duplicated the calibration failure.He replaced the oxygen (o2) sensor.The unit operated to the manufacturer's specifications.The suspect device was sent back to the manufacturer for further evaluation.

Event Description

It was reported that the electronic patient gas system (epgs) displayed a "failure to calibrate gas" error message.No other details regarding the nature of this event were provided.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician could not duplicate the reported complaint.The returned oxygen sensor was installed into a lab use only electronic patient gas system and calibrated three consecutive times.

Manufacturer Narrative

The reported complaint was confirmed.Per the data log review on (b)(6) 2020, each time the gas system calibration was attempted it failed with a 'o2 sensor out of range at calibration' (sensor value = 0) message.This indicated a bad o2 sensor or a connection issue to the sensor.The data log confirms the complaint.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
• MDR Report Key: 10813393
• MDR Text Key: 215518629
• Report Number: 1828100-2020-00429
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)100623
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

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: 801188
• Device Catalogue Number: 801188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 10/29/2020; 12/01/2020
• Supplement Dates FDA Received: 11/23/2020; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1