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

Model Number MCP00703309

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Kinked (1339)

Patient Problem Blood Loss (2597)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was stated that the tube, inserted in the roller pump, had a kink during surgery.Because of the kink, the tube burst.The roller pump sucked air and stopped finally.The patient experienced a massive blood loss and had to be reanimated.Surgery was delayed for 30 minutes.(b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.(b)(4).It was suspected that the occlusion of the pump inlet wasn't closed completely.However the occlusion of the outlet was closed completely.This could have led to the fact that little by little more tube was dragged in the raceway by the movement of the roller head towards the outlet side.At a certain length of tube which then accumulated in the roller head then led into a massive kinking of the tube.Finally the tube burst and the pump sucked air, what resulted in a pump stop.This is a wanted "stop intervention" of the heart lung machine in order to avoid pumping air into the patients blood circulation.In addition the device was investigated by a technician.Function and settings were checked.Maintenance was performed, error messages and interventions were checked.Functional check and test run was performed - ok.According to service order and service protocol, no parts were replaced and no failure and no safety defects could be detected.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 at this time it cannot be concluded that this is a systemic error.No corrective action is needed.

Event Description

(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: 6968635
• MDR Text Key: 89952064
• Report Number: 8010762-2017-00343
• 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: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00703309
• Device Catalogue Number: 701027652
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• Date Device Manufactured: 09/01/2009
• 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
• Patient Outcome(s): Life Threatening; Required Intervention