MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG SINGLE ROLLER PUMP MODULE

Model Number 701027652

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

It was reported that the display intermittently displays "eprom error" on power-up.No pt involvement.Ref - (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 maquet service tech evaluated the device and replaced the control board.Preventative maintenance was functional testing to factory specs was successfully executed.A supplemental medwatch will be submitted if add'l info becomes available.

• Brand Name: SINGLE ROLLER PUMP MODULE
• Type of Device: SINGLE ROLLER PUMP
• 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: 3847031
• MDR Text Key: 4618285
• Report Number: 8010762-2014-00142
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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: 03/14/2014,02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701027652
• Device Catalogue Number: MCP00703309
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2014
• Date Manufacturer Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1