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 Failure to Calibrate (2440); Improper Device Output (2953)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to (b)(4) / medwatch #1828100-2017-00430.This complaint is related to (b)(4) / medwatch #1828100-2017-00431.

Event Description

It was reported that the electronic patient gas system (epgs) displayed inaccurate values and was unable to be calibrated.No other details regarding the nature of this event were provided.

Event Description

Per clinical review: the customer has an advance perfusions system 1 (aps1) that has not been used clinically in over a year.The date of the incidents are unknown, and just a year was given on the occurrence 2015.The information that is available to the manufacturer is very scarce, even after numerous attempts to gather more information.There was not a trained individual performing maintenance or preventive maintenance on the aps1 and its components.The user facility biomedical engineer (biomed) was performing any procedure that needed done on the aps1.The complaint is that the oxygen concentration is 19% but the correct number should be 21%, and they cannot calibrate the electronic patient gas system (epgs).The date of the occurrence was not relayed on to the manufacturer, nor when the occurrence took place for the perfusion team.They have since changed the oxygen sensor, for they are now working with a manufacturer trained biomed.Since the changing of the oxygen sensor, the team has been able to calibrate it.

Manufacturer Narrative

The reported complaint was not verifiable.Diligence was unsuccessful for additional information.No device was returned to the manufacturer for evaluation.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: 6885884
• MDR Text Key: 88064274
• Report Number: 1828100-2017-00432
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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