MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. ADVANCED PERFUSION SYSTEM 1; APS1 (CENTRIFUGAL DRIVE)

Model Number 164268

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the white spring loaded compression levers that keep the centrifugal pump head locked into the handcrank motor were broken.The manual drive was changed out the for the case.The surgical procedure was completed successfully.There were no delays, no blood loss, and no adverse consequences to the patient.

Manufacturer Narrative

This complaint is related to medwatch #: 1828100-2014-00889, 1828100-2014-00842.The field service rep (fsr) confirmed the complaint.The fsr replaced the white latch, the latch's spring and the pump window cover.Only the white latch was returned to the manufacturer.It is unk how the spring and pump window cover went missing, but the latch would have held these parts in place.If additional info 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: APS1 (CENTRIFUGAL DRIVE)
• 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: 4189608
• MDR Text Key: 5099846
• Report Number: 1828100-2014-00841
• 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: 09/21/2014

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: Health Professional
• Device Model Number: 164268
• Device Catalogue Number: 164268
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2014
• Initial Date FDA Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2006
• 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