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

Model Number 70102.8674

Device Problem Failure to Auto Stop (2938)

Patient Problem No Patient Involvement (2645)

Event Date 11/18/2013

Event Type  malfunction  

Event Description

It was reported that prior to use on a pt, the perfusionist was setting up a hl20 and could not select the cardioplegia option on the single pump module.The roller pump module.The roller pump module was removed from use and replaced with another.The device was sent to the national service center for repair.(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary ag provides product failure investigation, analysis and resolution for the device described in this report.A supplemental medwatch will be submitted following receipt of add'l info.

• 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: 3633871
• MDR Text Key: 4203039
• Report Number: 8010762-2013-00139
• 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: 12/18/2013,11/19/2013

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: 70102.8674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/19/2013
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2013
• Initial Date Manufacturer Received: 11/19/2013
• 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