MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE; DWC

Model Number 70102.8718

Device Problems Infusion or Flow Problem (2964); No Flow (2991)

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

Event Date 06/03/2015

Event Type  malfunction  

Event Description

Description from the customer report: "unit not pushing water.Unit was still in use on patient when the malfunction was notified." no patient injury was reported.(b)(4).(b)(6).

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device (b)(4).The customer has decided not to have this unit repaired because they are going to purchase a new hcu30 instead.Therefore no conclusion is available.A supplemental medwatch will be submitted if additional information becomes available.

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) received a service report, the unit was repaired yet.The technician performed the following work on the unit in question.Cleaned stop, shunt and return valves; check unit using pcload; perform functional tests; verify unit meets factory specs; perform electrical safety tests; complete preventive maintenance with full calibration, functional testing and safety check to factory specifications.A supplemental medwatch will be submitted if additional information becomes available.

Event Description

(b)(4).

• Brand Name: MAQUET HCU30 DEVICE
• Type of Device: DWC
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strabe 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4894351
• MDR Text Key: 21791680
• Report Number: 8010762-2015-00782
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,consumer,health prof
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

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: 70102.8718
• Device Catalogue Number: 70102.8718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 07/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other