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

Model Number 801074

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.At set-point of 80% the central control monitor (ccm) read 80.6%, servomex o2 analyzer read 75.2% which is outside the limit of +/- 3%.The unit remained powered up for approximately 30 more minutes, then the srt tried calibrating a second time to see if the error was repeatable and received the following results: setpoint: ccm: o2 analyzer: 21%, 21.0, 21.0.30%, 30.6, 30.7.80% , 80.2, 79.9.100%, 99.7, 98.7.The srt replaced this o2 sensor as a result of the initial failure.He ran applicable verification tests.The unit operated to manufacturer specifications and was returned to clinical use.

Event Description

Upon receipt of the device, the service repair technician (srt) reported that the electronic patient gas system (epgs) failed the oxygen (o2) sensor reading accuracy portion of the verification test.There was no patient involvement.

Manufacturer Narrative

Updated blocks: device evaluated? and evaluation codes.During laboratory analysis, a lab use only (luo) electronic patient gas system (epgs) with the oxygen (o2) sensor installed, was within specifications regarding o2 accuracy.The product surveillance technician (pst) installed the returned o2 sensor into a luo epgs and connected the epgs to a system-1 simulator and central control monitor (ccm).He connected the epgs to o2 and air, entered a perfusion screen on the ccm.After the 15 minute warm-up period, calibration of the o2 sensor was initiated and passed.The measurement of the direct current (dc) output voltage from the o2 sensor at 5 liters per minute (l/min) and 100% o2 was 1.94 volts, which is within the specification of 0.55-2.758 volts.After initial calibration, he tested the o2 sensor at three set points.(b)(6).Calibrated the epgs a second time and retested at the same three set points.Nothing observed during visual inspection that would cause the failure.(b)(6).

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.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5474279
• MDR Text Key: 39756275
• Report Number: 1828100-2016-00139
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2016

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 Expiration Date: 05/12/2016
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Device Lot Number: 12804-018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 03/02/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/23/2016; 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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