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

Model Number 816570

Device Problems Fracture (1260); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's subsidiary, the issue was discovered during a demonstration.

Event Description

Upon receipt of the device, the user reported that when un-boxing the unit they heard a noise and found the main shaft of the roller pump to be broken.There was no patient involvement.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the main gut shaft to be broken with the nut attached.

Manufacturer Narrative

The reported complaint was confirmed.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

Updated blocks: d10 and h3.H3: 81 - evaluation is in progress, but not yet concluded.

• Brand Name: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8693593
• MDR Text Key: 147873062
• Report Number: 1828100-2019-00308
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001363
• UDI-Public: (01)00886799001363(11)190116
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816570
• Device Catalogue Number: 816570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1