MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH MAQUET HCU 40; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number HEATER-COOLER UNIT

Device Problems Fumes or Vapors (2529); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was stated that the hcu 40 sparked and fumed during the disinfection procedure.No patient involvement was stated.(b)(4).

Event Description

Initial reference: (b)(4).

Manufacturer Narrative

Maquet medical systems, usa (importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.Reference exemption # e2018002.Importer- maquet medical systems usa 45 barbour pond drive wayne, nj 07470.Contact person- (b)(6).The field service technician (fst) was onsite and replaced the defective printed circuit board(pcb).According to the fst the vacuum valves caused the incident.As they were damaged, water could pass the vacuum valves and arrived on the pcb.In contact with water the pcb generated sparks and fumes.As the root cause for the defective pcb is known (leaky vacuum valve), no further investigation for the pcb is necessary.The root cause for the defect of the vacuum valves is an inadequate cleaning procedure which degrades the functionality of the vacuum valve.Thus the failure could be confirmed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

• Brand Name: MAQUET HCU 40
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8429745
• MDR Text Key: 139323996
• Report Number: 8010762-2019-00071
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEATER-COOLER UNIT
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1