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 Problems Fluid/Blood Leak (1250); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This o2 sensor was in a (b)(6) express "small box¿ shipping box, and the box was not damaged.The other two o2 sensors in the shipment were good.The internal padding was adequate.The fsr never removed the sensor from the (b)(6) bag, as fluid could easily be seen inside the bag and fluid had absorbed into the information page inside the bag.The suspect part was returned to the manufacturer for further evaluation.

Event Description

Upon receipt of the device, the field service representative (fsr) reported that the oxygen (o2) sensor had leaked.This complaint is for a defective van stock part and is considered an "out of box" failure.There was no patient involvement.

Manufacturer Narrative

During the laboratory evaluation, the product surveillance technician (pst) observed gel had leaked out of the oxygen (o2) sensor.The o2 sensor passed calibration when installed into an electronic patient gas system (epgs).The pst wiped any excess gel that was not dry from the outside of the o2 sensor.He installed the returned o2 sensor into a lab-tested epgs and connected the epgs to a system-1 simulator and central control monitor (ccm).Connected the epgs to oxygen 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 (d/c) output voltage from the o2 sensor at 5 liters per minute (l/min) and 100% o2 was 2.04 volts which is within the specification of 0.55-2.758 volts.

Manufacturer Narrative

The reported complaint was confirmed.Supplier evaluation indicates that the nonconformance is a supplier issue and they are actively investigating process improvements.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: 5398780
• MDR Text Key: 37162184
• Report Number: 1828100-2016-00048
• 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: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/15/2016
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• 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