MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW CENTRIFUGAL PUMP SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number MCP00706037

Device Problems Air Leak (1008); Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 09/17/2016

Event Type  Death  

Manufacturer Narrative

No further incident information was provided by the customer.After the incident, a field safety technician (fst) had been sent for further investigation.According to service order # :(b)(4), and the service protocol dated on 2016-09-19, the rotaflow and the rotaflow drive (article no.: 70102.2161, serial no.: (b)(4)) passed the service tests.Additionally, a visual inspection had been performed whereas, no deviations were found.Performed electrical safety tests were passed, as well as the functional checks tests.No product related failure could be confirmed at this time.Therefore, no relationship between the reported incident and the patient death can be assumed.The investigation of the manufacturer is still pending.A supplemental medwatch will be submitted when further information becomes available.

Event Description

According to a press release of the customer: "it was reported that medical staff detected a low blood flow in the va-ecmo system and spotted gas bubbles in the tube containing the blood flowing from the patient to the va-ecmo machine.The patient died.The hospital checked all emco machines of the same models after the incident and no defects have been detected so far." no device alarms were reported during the incident.(b)(4).

Manufacturer Narrative

The device has been evaluated by (b)(4).According to (b)(4) investigation report, the investigation got following results: the customer asked "if the del error can produce air bubbles and therefore the incident is somehow connected.", since del error displayed two days before the incident occurred.According to (b)(4) there is no relation due to those 2 different cases, since the pump cannot be started when [del.- error] is displayed.If the triggering error (the faulty solder contact) occurs only after startup of device,then an audible alarm occurs in the stand-alone mode, the flow display shows [----] and the status display shows the error message [fault-bub].If the bubble intervention is activated, the pump stops additionally.In free mode, an audible alarm is triggered and the flow display shows[----].An additional failure was detected during investigation.Rotaflow console does not permanently safe the zero-flow setting.This failure will be handled in a separate complaint to track and trace.Thus the failure could not be confirmed.The data is also being handled through a designated maquet cardio-pulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.The device was checked by the technical supervisor.A pm service was requested by the hospital.No problems were found regarding the rf device.

Event Description

(b)(4).

• Brand Name: ROTAFLOW CENTRIFUGAL PUMP 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: 6036872
• MDR Text Key: 57764731
• Report Number: 8010762-2016-00634
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K991864
• 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: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MCP00706037
• Device Catalogue Number: 70104.3290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2016
• Initial Date FDA Received: 10/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2008
• 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): Death