MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number HEATER COOLER UNIT HCU 30

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up emdr will be submitted when additional information becomes available.

Event Description

The failure occurred in (b)(6).It was reported that the hcu 30 showed the error ¿1008- main output pressure sensor error¿ during heating process in clinical use.The device has been restarted 3 times.No indication of actual or potential for harm or death.Complaint number: (b)(4).

Event Description

Complaint number: (b)(4).

Manufacturer Narrative

Initially it was reported that the unit had a flow zero function fail.The affected drive has been sent to germany for repair by the manufacturer emtec under rma#40793.Drive received in rastatt on (b)(6) 2020; functionaltest service rastatt (b)(6) 2020; failure confirmed; forwarded to emtec (b)(6) 2020; back from emtec (b)(6) 2020; funtionaltest after emtec in rastatt (b)(6) 2020.According to the service report of emtec rma2020-10210 dated on 2020-07-02 the 0 flow was over 3.4 lpm, this has to be zeroed several times for an externally generated flow.The housing foot was loose.The failure could be confimed.Follow work has been done by emtec: offset resetted replaced housing foot the rotaflow drive passed all tests.The rotaflow drive was tested in rastatt according to the service protocol (see service report 10478261 dated on 2020-07-02).The most possible root causes for the reported failure "flow zero function fail" could be determined as misshandling according to the manufacturer emtec.The reported failure "flow zero function fail" occurred during testing by the engineer and could be confirmed.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required the ocurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: HEATER COOLER UNIT
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10400823
• MDR Text Key: 202709548
• Report Number: 8010762-2020-00256
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEATER COOLER UNIT HCU 30
• Device Catalogue Number: 70102.8718
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1