MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HL20 TWIN PUMP

Catalog Number 70103.5075

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2014

Event Type  malfunction  

Event Description

It was reported, that a twin roller pump stopped during cardioplegia.(b)(4).

Manufacturer Narrative

A maquet service technician found the pump had a manufacturing defect and will have the part replaced under warranty.Pump name: tpm 20-330 twin roller pump.Pump serial number: (b)(4).Pump part number of the hl 20: (b)(4).A supplemental medwatch will be submitted when additional information becomes available.

• Brand Name: MAQUET HL20 TWIN PUMP
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; restatt ; GM
• Manufacturer Contact: michael campbell ; kehler strabe 31; rastatt 76537 ; GM 76537 ; 2229321132
• MDR Report Key: 4286022
• MDR Text Key: 5224646
• Report Number: 8010762-2014-01228
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K984338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 70103.5075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2014
• 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
• Patient Outcome(s): Other