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

Model Number 801188

Device Problem Failure to Calibrate (2440)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

The fsr replaced the o2 sensor.The unit operated to the manufacturer's specifications.The suspect part was sent back to the manufacturer for further evaluation.

Event Description

The field service representative (fsr) reported that during field service installation of the device, the electronic patient gas system (epgs) would not calibrate the oxygen (o2) sensor.There was no patient involvement.

Manufacturer Narrative

Per the field service representative, a second calibration was attempted that also failed.

Manufacturer Narrative

Updated block: h6.The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed that the oxygen (o2) sensor was failing calibration.Upon visual inspection, the pst identified a material was leaking from inside the o2 sensor causing the sensor to fail during calibration.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
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 10774931
• MDR Text Key: 214588862
• Report Number: 1828100-2020-00420
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000588
• UDI-Public: (01)00886799000588(11)190508
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2021

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: Other
• Device Model Number: 801188
• Device Catalogue Number: 801188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 11/20/2020; 02/08/2021
• Supplement Dates FDA Received: 12/15/2020; 02/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MECHANICAL FLOW METER