MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 701034642 - HCU 30

Device Problems Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

When further information becomes available a follow up emdr will be submitted.

Event Description

It was reported that the hcu30 causing that the breaker tripped.The heater had an eletrical leak.Complaint # (b)(4).

Manufacturer Narrative

It was reported that the hcu 30 causing the breaker in the operation room tripped.According to the field service technician on 2020- 02-18 via communication grid the hcu 30 is at the local getinge office.The technician found, that the 701034044 mcp00704749 # heater card 230v had a short circuit.According to the service report#43285926 dated on 2020-03-16 the maquet service technician replaced the 701034044 mcp00704749 # heater card 230v.All function tests passed.The device is back in clinical use.The most probable root cause of the tripped breaker in the operation room is a short circuit on the hcu30 heater card 230v (material#70103.4044).Thus the reported failure "breaker tripped" can be confirmed.The reported failure happened during start up of the device.The hcu 30 which was used, was responsible for this complaint.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrance rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint # (b)(4).

• Brand Name: HEATER COOLER UNIT
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9715909
• MDR Text Key: 200421606
• Report Number: 8010762-2020-00064
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K031554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701034642 - HCU 30
• Device Catalogue Number: 701034642
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1