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

Model Number HCU 40

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch will be submitted after new information has been received.

Event Description

It was reported that the hcu 40 had a pump stop during cleaning cycle with an alarm message flow too low.Complaint number: (b)(4).

Manufacturer Narrative

According to the service report# (b)(4) dated on 2019-07-09 the field service technician (fst) replaced the hcu 40_valve kit (flow & 3-way) (material#70107.1778, serial#unknown).The fst performed the diagnosis and passed all the specifications.The device is back in clinical use.No root cause determination is applicable, the defective part is not available for investigation.The reported failure could be confirmed.The occurrence 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.

Event Description

Complaint number: (b)(4).

• 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: 8775267
• MDR Text Key: 150544885
• Report Number: 8010762-2019-00209
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K031554
• 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: 08/12/2019

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 40
• Device Catalogue Number: 701044054
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 07/31/2019
• Supplement Dates FDA Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1