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

Model Number 801763

Device Problem Loss of Power (1475)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Per the field service representative (fsr), the perfusionist found a breaker that was tripped on the rear of the hlm prior to starting his case.The fsr could not duplicate the reported complaint.The unit operated to the manufacturer's specifications.

Event Description

It was reported that the heart lung machine (hlm) lost power.No other details regarding the nature of this event were provided.

Manufacturer Narrative

Per fsr, the facility had power interruption the night before the event occurred.

Event Description

Additional information received that there was no adverse consequences to the patient.

Manufacturer Narrative

Per data log analysis, on (b)(6) 2020 the system is powered up on battery backup at 06:27:16 am.At 08:35:44 am the system switches to alternating current (ac) power.It is possible the circuit breaker was tripped and then reset but there is no way to tell for sure from the log.The log does confirm ac power was lost.

Manufacturer Narrative

The reported complaint was confirmed.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: 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: 10836139
• MDR Text Key: 216139284
• Report Number: 1828100-2020-00438
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000656
• UDI-Public: (01)00886799000656(11)180327
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1