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

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Improper or Incorrect Procedure or Method (2017)

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

Event Date 06/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Customer stated that he is always using the hl20 without bubble sensor.Therefore he overrides the bubble sensor.But when he disabled accidently the override function and the pump stopped no audible alarm was generated.(b)(4).

Manufacturer Narrative

No further investigation is needed since the device works within specification.The customer reported his dissatisfaction with the new version of hl20 regarding the bubble alarm.It has to be noted, that the older version of hl20 device as well as the 3rd edition device do not generate an alarm, if the activation of the bubble sensor is removed.But of course in both cases the pump will stop when bubble sensor and level sensor are activated.Therefore, no product malfunction occurred.So the hl20 has worked within specification.Furthermore, the medical staff in (b)(6) is trained into the functionality of hl devices otherwise the person is not allowed to work on this device.Thus the failure could not be confirmed.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.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition no device malfunction has been determined.No corrective action is needed.

Event Description

(b)(4).

• Brand Name: MAQUET 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: 5720787
• MDR Text Key: 48253159
• Report Number: 8010762-2016-00380
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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