MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HL-20 INTEGRATED PERFUSION SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number MCP00917741

Device Problems Device Inoperable (1663); Defective Component (2292)

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

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

Customer reported that hl20 device (sn:(b)(4)) level sensor does not work because he check the during the priming time arterial pump module does not stop.Field safety engineer did check the level sensor another new one our stock same error after then we did check the another bubble-level module new one device level sensor works to normally.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

Customer described:" level sensor does not work because he check the during the priming time arterial pump module does not stop.We did check the level sensor another new one our stock same error after then we did check the another bubble-level module new one device level sensor works to normally.(b)(4).

Manufacturer Narrative

The replaced part will be send to lab for further investigation.Rma (b)(4) for returning the goods: received on 2017-08-04 and send to lce.Investigation performed on 2017-10-12: the apm (mat.#70105.3014) serial no.(b)(4), has been received for investigation.It was connected to the hl20 and failure occurred and could be confirmed.The system control panel (scp) shows a sensor failure even the sensor is connected.The resistance of the level-bubble-control-board of the apm was discolored.The resistance is higher and take 18 o instead of 10 o as specified.Furthermore the transistor t6 shows a very low crossing voltage of basic-emitter-diode.Via r43 the current consumption of the level sensors were measured and via t6 the supply voltage is controlled.This failure could be confirmed.Most probable root cause was a short circuit in the level sensor.This damaged two elements of the apm.

Event Description

Internal reference: (b)(4).

• Brand Name: HL-20 INTEGRATED PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6701731
• MDR Text Key: 79789110
• Report Number: 8010762-2017-00218
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00917741
• Device Catalogue Number: 701043263
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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