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

Model Number HCU 30

Device Problems Insufficient Heating (1287); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(4).It was reported that the hcu30 had the error ¿1004¿ (main heater temp.Sensor error) during surgery.No health damage to patients.

Event Description

Compaint (b)(4).

Manufacturer Narrative

Hcu 30 displayed an error "1004".According to the service report (b)(4) dated on 2020-09-28: an error occurred while using it in the hospital, and when the getinge field service technician (fst) pulled it up to the company, it was not reproduced.Just in case, the fst replaced the actuator on the main side.Valve cleaning was carried out.The fst ran for 3 days after the work and confirmed that it can be used without problems.Replacement parts: 701034052 actuator 24v ac / dc 50 / 60hz.Similar failure "error 1004" was already investigated in a similar complaint no.(b)(4) on 2014-10-02 with life cycle engineering (lce) investigation report no.2545: the most probable root cause of the reported malfunction is a slight oxidation layer is inside the 3-way valve.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 reported failure occurred during treatment.The reported failure "1004" can be confirmed.The hcu 30 which was used, was responsible for this complaint.The occurrance 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: 10559132
• MDR Text Key: 207723547
• Report Number: 8010762-2020-00304
• 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: 10/06/2020

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: HCU 30
• Device Catalogue Number: 7010.28718U
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/12/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 10/06/2020
• Supplement Dates FDA Received: 10/06/2020
• Patient Sequence Number: 1