MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HEATER-COOLER UNIT HCU 40 HIGH VOLTAGE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 701044054

Device Problems Insufficient Heating (1287); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the hcu40 pulls air into the main side of the oxygenator and caused poor heating and high noise.This incident occurred always during the warming phase.The problem exists since the fsca (b)(4) (replacement of the shunt- and flow valves) was performed.This incident was repeated with two times during the surgery and caused poor heating and the error message "water flow too low".Internal reference: (b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer: (b)(4).After several requests no significant information were received.Therefore this complaint is closed.If new information will be submitted this complaint could be re-opened.Thus the failure could not be confirmed.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.A supplemental medwatch will be submitted if new information has been received.

Event Description

Internal reference: (b)(4).Customer reference: onesupport # (b)(4).

• Brand Name: HEATER-COOLER UNIT HCU 40 HIGH VOLTAGE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7215397
• MDR Text Key: 98426928
• Report Number: 8010762-2018-00034
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701044054
• Device Catalogue Number: 701044054
• Date Manufacturer Received: 01/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1