MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Death (1802)

Event Date 07/12/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A supplemental medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

Received a facility medwatch from the fda # (b)(4) on december 14, 2015 which is related to a previous complaint we had noted as (b)(4) for a hls set; with no mention of a cannula.On (b)(6) 2015, facility medwatch from the fda # (b)(4) was received and it was noted during replacement of the circuit the cannula became dislodged and the patient exsanguinated during cardiac compressions.The patient was recannulated and ecmo therapy was resumed using the new circuit.Patient expired on (b)(6) 2015 as care was withdrawn due to neurological status of the patient.(b)(4).

Manufacturer Narrative

(b)(4).According to the information received on feb 2,2016 and provided by one member of the perfusion group at (b)(6) hospital the cannula device in question was not a maquet cannula.

Event Description

(b)(4).

• Brand Name: CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5351137
• MDR Text Key: 35277049
• Report Number: 8010762-2016-00013
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2015,12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2015
• Distributor Facility Aware Date: 12/14/2015
• Device Age: MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2015
• Date Manufacturer Received: 02/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 15 MO