MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG TWIN ROLLER PUMP; TWIN ROLLER PUMP ON HL 20 CONSOLE BASE

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2014

Event Type  malfunction  

Event Description

It was reported that a twin roller pump on the heart lung machine was noisy and displayed a pump head error.No patient involvement.(b)(4).

Manufacturer Narrative

(b)(4).Maquet provides product failure investigation, analysis and resolution for the device described in this report.A maquet service technician evaluated the device and confirmed the ticking noise when the head was running at low rpm (between 50 and 70 rpm).The device was disassembled and the top belt appeared to be frayed.The pump was returned to the repair depot to have the belts replaced and the head alignment checked.A loaner pump was provided.A supplemental medwatch will be submitted when additional information becomes available.

• Brand Name: TWIN ROLLER PUMP
• Type of Device: TWIN ROLLER PUMP ON HL 20 CONSOLE BASE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strabe 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 4176619
• MDR Text Key: 5026132
• Report Number: 8010762-2014-00272
• 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
• Type of Report: Initial
• Report Date: 07/24/2014,07/10/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2014
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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