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

Model Number HEATER-COOLER UNIT

Device Problems Self-Activation or Keying (1557); Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).A maquet field service technician was on site and investigated the unit in question.The technician troubleshooted the device and could confirm the failure.According to the service report: device reported to that the compressor would not stay on while cooling.They could initialize it by changing the ice block size but it was still not performing adequately.Upon review by hospital biomed, ice block did not build in tank section 'b' - main exit.Device was rebooted and the ice block then finish building but the valve was not charging properly.Replaced valve coil.Emptied device water.Chemical residue visible on ice sensors.Cleaned tank temperature sensors and ice sensors.Completed inspection - passed all functional test.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.A supplemental medwatch will be submitted if new information has been received.

Event Description

It was reported that the compressor of the hcu40 keeps failing.The compressor was unpredictably turning on and off during a case while cooling the patient.There was no known issue with the compressor.According to the technician the most probable root cause is a user error (improper following of cleaning procedure).There were no negative consequences to the patient and no medical intervention was necessary.If this incident would reoccur it could have negative consequences for the patient, therefore this report is required.(b)(4).

• Brand Name: MAQUET HCU 40
• 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: 7472738
• MDR Text Key: 107460845
• Report Number: 8010762-2018-00157
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• Date Device Manufactured: 12/01/2016
• 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