MAUDE Adverse Event Report: MAQUET CARDIOPULMOARY AG MAQUET HL-20 TWIN PUMP; FLOWMETER,BLOOD, CARDIOVASCULAR

Model Number MCP00703279

Device Problems Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)

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

Event Date 10/21/2011

Event Type  malfunction  

Event Description

On (b)(6) 2011, at (b)(6), the customer reported that after the twin pump module tpm 20-330, twin roller pump (article number: 70102.8694, serial number: (b)(4)) attached to the hl20 is configured as cardioplegia (left pump) and cardioplegia-slave (right pump) that over time the configuration then returns to the default free mode.In addition, the cardioplegia-slave has displayed an "rpm-diff" error message.The hospital reported this to the maquet service representative on (b)(6) 2011.(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary ag provides product failure investigation, analysis, and resolution for the device described in this report.The service technician checked both pump head speeds and verified pump head speeds.There is no documentation that any repair was performed.The device was not returned to the manufacturer.(b)(4).

• Brand Name: MAQUET HL-20 TWIN PUMP
• Type of Device: FLOWMETER,BLOOD, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 76437 ; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMOARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4280441
• MDR Text Key: 5228607
• Report Number: 8010762-2014-00526
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2011

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: MCP00703279
• Device Catalogue Number: 70102.8694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/29/2011
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2011
• Initial Date Manufacturer Received: 10/29/2011
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2005
• 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