MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU 30 DEVICE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 70102.8718

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A supplemental medwatch will be submitted when additional information becomes available.

Event Description

"it was reported that the hcu30 device displayed the error message "7002/2" which indicates an issue within the communication between the control board and display/io board." additional information: this event occurred during a routine check so there were no patient involvement.(b)(4).

Manufacturer Narrative

On (b)(6) 2016 08:53 am (gmt-5:00) added by (b)(6) ((b)(4)): a maquet field service technician was on site and investigated the unit in question.The technician checked the unit and could not confirm the problem.The device worked fine.The unit was tested to factory specifications.All tests were performed successfully.A supplemental medwatch will be submitted if additional information becomes available.

Event Description

(b)(4).

Manufacturer Narrative

Due an error that was made in the initial assessment where the designated complaint handler incorrectly interpreted a statement from the hcu30 device¿s instruction for use (ifu), this reported issue was made reportable.Consequently, a service order was requested if any service was performed on the device.A service order was provided by the ssu contact to the designated complaint handler.A follow up medwatch report was then generated based on the information provided in the service order.However, upon review of the service order, the qa consultant found that the serial number on the report was incorrect.The wrong service order was sent and consequently the first follow up report was based on the information provided in the service order provided.In essence no investigation was required as the reported issue was resolved between the ssu contact and the maquet technician through the communication via msupport.The maquet technician suggested to the customer to verify that all connections are in good condition and to possibly clean the contacts with contact cleaner.The ssu contact confirmed that the suggestion resolved the issue.This final follow-up medwatch report serves to notify the regulatory agencies that the initial and first follow-up medwatches were generated in error as this complaint is not reportable and the reported issue is resolved.

Event Description

(b)(4).

• Brand Name: MAQUET HCU 30 DEVICE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5221649
• MDR Text Key: 31428080
• Report Number: 8010762-2015-01161
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70102.8718
• Device Catalogue Number: 939001#HCU30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1