MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE; HCU30 200V-240V

Model Number 70102.8718

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

It was reported that water would not go into the line on this hcu30 unit; would not empty hoses.No pt involvement.Reference: (b)(4).

Manufacturer Narrative

(b)(4).A maquet service tech investigated and repaired the device.Three stop valves and a shunt were replaced.Functional and safety tests were successfully executed.The unit was returned to service.A supplemental medwatch will be submitted as soon as add'l info becomes available.

• Brand Name: MAQUET HCU30 DEVICE
• Type of Device: HCU30 200V-240V
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond dr; watne, NJ 07470 ; 9737097753
• MDR Report Key: 3823872
• MDR Text Key: 4403331
• Report Number: 8010762-2014-00065
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2014,01/24/2014

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/24/2014
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2014
• Initial Date Manufacturer Received: 01/24/2014
• Initial Date FDA Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2005
• 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