MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HLS SET

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 06/01/2014

Event Type  Death  

Event Description

It was reported that an individual not employed with the facility, communicated that the facility had a patient expire while on the device.They indicated an autopsy showed the patient was full of air.There is no indication that the death was attributed to the disposable set.(b)(4).

Manufacturer Narrative

(b)(4).Maquet provides product failure investigation, analysis and resolution for the device described in this report.A supplemental medwatch will be submitted if additional information becomes available.

• Brand Name: MAQUET HLS SET
• Type of Device: HLS SET
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strabe 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond dr.; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 4036389
• MDR Text Key: 4880646
• Report Number: 3008355164-2014-00138
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2014,07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/18/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2014
• Date Manufacturer Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death