MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOHELP-I SYSTEM

Model Number 70104.8012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 06/11/2012

Event Type  Death  

Event Description

It was reported that a cardiohelp was on a pt for twenty one days.The customer complained of no flow with a negative inlet pressure of about 130 mmhg.The medical decision was made to dehydrate the pt as this was felt to be best for the lungs.The medical staff removed the head from the cardiohelp and were hand cranking at about 5000rpm before the perfusionists arrived.Hand cranking continued for approximately 30-40 minutes before a rotaflow was cut into the circuit for use.This report is being issued due to a patient's death.The hospital reported the incident was related to the patient's condition and not to the device.(b)(4).

Manufacturer Narrative

(b)(4).Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.This complaint has been reopened due to an internal complaint review process.It was assessed that the incident should have been reported within 30 days of the aware date in 2012.Additionally, a (b)(4) field technician evaluated the device and could not find any deficiencies, so the device was not returned.The hospital placed the device in use shortly after the incident and did not report any issues related to the device.No further actions will be initiated.

• Brand Name: MAQUET CARDIOHELP-I SYSTEM
• Type of Device: CARDIOHELP-I SYSTEM
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3677097
• MDR Text Key: 4242899
• Report Number: 8010762-2014-00055
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/19/2014,06/12/2012

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 70104.8012
• Device Catalogue Number: 70104.8012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/17/2014
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/12/2012
• Initial Date FDA Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• 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