MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET VARIO TWIN, HL 20, 4-PUMPS

Catalog Number 70104.3262

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 02/23/2015

Event Type  malfunction  

Event Description

It was reported that the during self test single roller pump moving high speed and showing errors safety s and run away.The safety-s error refers to a failure regarding a recurring deviation between the measured and set value of the pump speed of at least 10%.Example: the pump speed is set with 1000 rounds per minutes (rpm) and the actual speed is measured on the pump head with greater than 1100 rpm.In order to protect the pt from excessive pump speed, an automatic pump stop is generated together with the safety-s error.In order to restart the pump, the user has to follow the instructions in the user manual.No known consequences to the pt.No further info have been provided to the mfr.(b)(4).

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device, maquet cardiopulmonary (b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.Field safety technician checked the unit and found the problem on the motor control board, which needs to be replaced.Field safety technician checked with another pump parts and tested and found that motor control board was defective.Part has to be replaced against warranty.

• Brand Name: MAQUET VARIO TWIN, HL 20, 4-PUMPS
• Type of Device: MAQUET VARIO TWIN, HL 20, 4-PUMPS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321122
• MDR Report Key: 4620303
• MDR Text Key: 5658462
• Report Number: 8010762-2015-00262
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K984338
• 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: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 70104.3262
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other