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

Model Number 70103,5075

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013, at the (b)(6) hospital, (b)(6), it was reported that the tpm 20-330 twin roller pump module serial number (b)(4) displayed a head error on the right side pump when powered on.The device was removed from service and the customer was given a loaner unit.The non-conformity report indicates that the failure occurred prior to use on a patient.(b)(4).

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The unit was investigated by a ssu service technician and the optical tachometer pcb was found to be defective and was replaced.(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: 4944755
• MDR Text Key: 6257880
• Report Number: 8010762-2014-00975
• 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: 12/19/2013

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
• Device Model Number: 70103,5075
• Device Catalogue Number: MCP00703323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/19/2013
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2013
• Date Manufacturer Received: 12/19/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• 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