MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HEATER-COOLER UNIT HCU40; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 701044054

Device Problem Component Missing (2306)

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

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Description from the customer report: it was reported that the hcu 40 had no ice in the tank during patient treatment.There were no negative consequences for the patient.(b)(4).

Event Description

(b)(4).

Manufacturer Narrative

(b)(6): the customer stated that there was no ice in tank after several hours of operation.A field service technician has been sent out and investigated the device.Technician switched off the pump, only the compressor was running.Tank temperature dropped from 24.8°c to 23,9°c after 30 minutes.Pressure of cooling circuit was low.Technician found that the level of refrigerant was low but couldn't found a leak.Thus the failure could be confirmed.Since no parts were replaced and it was unclear whether the failure occurred due to a leakage or due to a too small amount of refrigerant, no most probable root cause could be determined.According to service report dated on (b)(6) 2017: refrigerant was refilled and device tested for 3 days.Device was working properly.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

(b)(4).

• Brand Name: MAQUET HEATER-COOLER UNIT HCU40
• 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: 6490083
• MDR Text Key: 72945715
• Report Number: 8010762-2017-00122
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130300
• 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,Followup,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1