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

Model Number 70102.8692

Device Problems Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013 at (b)(6), it was reported through the support system complaint number 1071 that the control board on the tpm 20-330 twin roller pump module serial number (b)(4) was defective after the unit was upgraded to software version 2.5.The ssu reported that the unit displayed various errors.Upon request for further information, the ssu said that it was not possible to operate the device in a program mode (only free mode was available).(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 device was evaluated by a ssu technician and the control board was found to be defective and was replaced.The control board was returned to mcp in germany for investigation.During the investigation, the device displayed a 'no comm' error.The cause of the error was determined to be a damaged dc/dc converter.The damage was caused by a mechanical force which lifted two of the 8 pins of the dc/dc converter.It is likely that the damage occurred during the software update where the control board was pulled out of the tpm housing and the eeprom is changed.(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: 4944781
• MDR Text Key: 6037215
• Report Number: 8010762-2014-00878
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K984338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2013

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: 70102.8692
• Device Catalogue Number: MCP00703277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/31/2013
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2013
• Date Manufacturer Received: 07/31/2013
• 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