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 6382

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) verified the reported complaint.A replacement flow sensor was ordered to be sent to the customer to install.The fsr also advised the customer to retain the old flow sensor for return to the manufacturer for evaluation.The unit operated to manufacturer specifications and was returned to clinical use.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the flow sensor hinge pin was loose and falls out when in vertical position.The spring was missing also.The device was not changed out.The surgical procedure was completed successfully.There was no blood loss nor adverse consequences to the patient.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Event Description

Updated information: there was no delay and no harm to the patient.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) found the hinge pin to be loose (falls out easily) and the door hinge spring was missing.The door-latch mechanism is fully functional and allows proper attachment to the 3/8¿ tubing as designed.The sensor could be properly attached to tubing and was functional.The pst manipulated the returned flow sensor cabling at both ends and throughout the cable length.The flow reading remained constant throughout.He tested the upper (positive) range of the returned sensor and the flow rate displayed properly throughout the positive range 0 to 9.9 liters per minute (l/min).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: 5597042
• MDR Text Key: 44029200
• Report Number: 1828100-2016-00275
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6382
• Device Catalogue Number: 6382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• 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