MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP SYSTEM

Model Number MCP00952291

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a communication error occurred.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary ag provides product failure investigation analysis and resolution for the device described in this report.The device in question will be sent to maquet (b)(4) for investigation.A supplemental-medwatch will be submitted when add'l info becomes available.

Manufacturer Narrative

The manufacturer received the product in question for investigation.The rfd (rotaflow drive) was forwarded to a supplier for further evaluation and repair.During the suppliers investigation, the additionally reported failure of a defective cable could be confirmed.It was determined that most likely due to improper handling, the connection cable was torn from the connector plug.It could also be concluded that this defect also caused the reported communication error.The defective connector is handled in a separate complaint.In addition several other damages were found on the rfd and were handled in additional complaints.The connection cable including the connector was replaced.A system test was performed according to service protocol.

Event Description

(b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP SYSTEM
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4859156
• MDR Text Key: 5847538
• Report Number: 8010762-2015-00724
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2015

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: MCP00952291
• Device Catalogue Number: 70102.2161
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 06/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2016
• 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: Unknown
• Patient Sequence Number: 1