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

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 09/05/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013 it was reported by the (b)(4) at maquet medical (b)(4) through the msupport system complaint number (b)(4) that the tpm 20-330 twin roller pump module serial number (b)(4) displayed a beltslip error when running at 250 rpm but the display indicated 119 rpm.The rpm was measured with an external tachometer and it indicated 119 rpm.

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The device was evaluated by a (b)(4) technician and the optical tacho board, motor belt and belt pulley were replaced and the issue was resolved.(b)(4).

• Brand Name: HL-20 TWIN PUMP
• Type of Device: FLOWMETER, BLOOD, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4944784
• MDR Text Key: 6639092
• Report Number: 8010762-2014-00914
• 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: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/05/2013
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2013
• Date Manufacturer Received: 09/05/2013
• 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: Reuse
• Patient Sequence Number: 1