MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOPLUMONARY AG; RPM 20-320 SINGLE ROLLER PUMP

Model Number MCP00703239

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2014

Event Type  Injury  

Event Description

It was reported that the circuit was primed and the pump was moved, plugged in an re-circulated.The device over heated and the high temperature alarm went off.Another roller pump from another device was brought in and re-circulated.No bypass was necessary.No reported patient effect.(b)(4).

Manufacturer Narrative

The customer unit has been returned to the service depot for repair.A supplemental medwatch will be submitted when additional information becomes available.(b)(4).

• Brand Name: MAQUET CARDIOPLUMONARY AG
• Type of Device: RPM 20-320 SINGLE ROLLER PUMP
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4169434
• MDR Text Key: 20660739
• Report Number: 8010762-2014-00790
• 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: 10/08/2014,09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00703239
• Device Catalogue 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: 09/10/2014
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2014
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2005
• 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
• Patient Outcome(s): Other; Required Intervention