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

Model Number 701034642 - HCU 30

Device Problems Insufficient Heating (1287); Temperature Problem (3022); Radiation Output Problem (4026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2020

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 there was no circulation of cool water during operation.To complete the operation, they had to put hot water into the water tank to melt the ice block.No health damage to the patient.

Event Description

Complaint (b)(4).

Manufacturer Narrative

The reported failure "no circulation of cool water" could be confirmed.According to the communication in getinge complaint system dated 2020-02-19 the getinge field service technician (fst) informed that the ice sensor of the hcu 30 device was replaced.The replaced ice sensor was requested for further investigation in life cycle engineering (lce) with rma #(b)(4) on 2020-03-13.Part was received on 2020-04-09.Lce performed the investigation according to report #(b)(4) on 2020-04-20: the investigated ice sensor was destroyed through corrosion.Electrical resistances for two out of three ntcs (negative temperature coefficient thermistor) showed readings significantly off spec.The most probably root caused was corrosion by water and cleaning agents leaking into the sensor.The reported failure "no circulation of cool water" occurred during patient treatment.The hcu 30 which was used, was responsible for this complaint.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 occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿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: 9652827
• MDR Text Key: 190536419
• Report Number: 8010762-2020-00042
• 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
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701034642 - HCU 30
• Device Catalogue Number: 701034642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1