MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (ROLLER PUMP)

Model Number 801041

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump display was cutting in and out.As a result, an alternate device was employed.There was approximately a ten minute delay.The surgical procedure was completed successfully.There was no blood loss nor adverse consequences to the pt.Per the clinical review on (b)(6) 2014: according to the perfusionist (ccp), shortly after the start of cpb, the arterial roller pump stopped and when the stop was observed, the local display of the pump was blank.The display returned in a few seconds, but was garbled to an extent.The arterial pump was able to be re-started and used, but the clinical team elected to change out the pump prior to cardioplegic arrest.The venous return line was clamped and the pt was weaned from cpb with this roller pump and the pump was stopped and the arterial line was clamped.The pt heart rhythm and blood pressure were stable as the pump was changed.The tubing in the arterial pump was removed from the roller pump and placed in a back-up roller pump.The occlusion was checked as was tube size (pump display).The ccp elected to use the pump without re-assigning as the arterial pump.Thus the arterial pump was not linked to the safety systems being used (e.G.Air bubble detector [abd], level, and pressure).These safety systems would still function, as intended, but this replaced roller pump would not respond to these clinical events.After the replacement pump function was verified, cpb was re-initiated as the venous and arterial clamps were removed from the tubing and arterial pump flow gradually increased to target flow rate.The ccp estimated a delay of about ten minutes in the surgical procedure as the new pump was being placed and verified.The remainder of the procedure was without issue and there were no functional issues with the arterial pump or any other device in the cpb circuit.The case was completed successfully and the pt was weaned from cpb without difficulty.There was no associated blood loss and there was no harm observed.

Manufacturer Narrative

This complaint is related to mdr # 1828100-2014-01126.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS 1 (ROLLER PUMP)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4366125
• MDR Text Key: 18641847
• Report Number: 1828100-2014-01118
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801041
• Device Catalogue Number: 801041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2005
• 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
• Patient Outcome(s): Required Intervention