MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU 30; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Catalog Number 701044054

Device Problems Insufficient Cooling (1130); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).(b)(6).A field service technician has been sent out for investigation on 2018-04-27 and stated that the ice sensors were showing lower values on a1, b1 and c1 when ice was present.Thus the failure could be confirmed.Since no parts were replaced, no further investigation could be performed.However the most probable root cause for the occurrence of the failure were polluted ice sensors.According to service order # (b)(4) the technician cleaned the ice sensors.Device rebuilt the ice blocks and technician verified the ice sensors.According to the service protocol, no safety or functional defects were detected.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.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.

Event Description

It was stated that the device would not build ice after about four hours into a case.In order to obtain cooling, ice cubes were added into the device.No patient injury was reported.Internal reference: (b)(4).

• Brand Name: MAQUET HCU 30
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 7494820
• MDR Text Key: 108159040
• Report Number: 8010762-2018-00163
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1