MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOPULMONARY AG; HL 20 4-PUMPS CONSOLE BASE

Model Number MCP00702643

Device Problem Failure to Auto Stop (2938)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2013

Event Type  malfunction  

Event Description

It was report that the roller pump module would not allow cardioplegia mode to be selected as an option on any roller pump module that was connected to the same hl20 console.The device was sent to the national service center for repair.No pt involvement.(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.A loaner unit was sent to the site.A supplemental medwatch will be submitted if add'l info becomes available.

• Brand Name: MAQUET CARDIOPULMONARY AG
• Type of Device: HL 20 4-PUMPS CONSOLE BASE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3633940
• MDR Text Key: 3986095
• Report Number: 8010762-2013-00141
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943803
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/18/2013,11/26/2013

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: MCP00702643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2013
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2013
• Initial Date Manufacturer Received: 11/26/2013
• Initial Date FDA Received: 01/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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