MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL.; DIFFUSION MEMBRANE OXYGENATOR

Model Number 70105.3824

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2014

Event Type  Injury  

Event Description

It was reported that during ecmo (extra corporeal membrane oxygenation), an oxygenator had to be changed out of the circuit after flow dropped drastically over a few seconds and remained.The transmembrane pressure was several hundred.After the change out, flow returned to normal.The device was in use for 12 hours.(b)(4).

Manufacturer Narrative

(b)(4).Maquet provides product failure investigation, analysis and corrective actions for the device described in this report.Based on the reported event and our investigation, the reported event was caused by the use that is beyond the usage described in our labeling and cleared intended use.A supplemental medwatch will be submitted if additional information becomes available.(b)(4).

• Brand Name: BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL.
• Type of Device: DIFFUSION MEMBRANE OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; hechinger strasse 38; hirrlingen ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice krebs ; 45 barbour pond dr.; wayne, NJ 07470 ; 9737097359
• MDR Report Key: 4169442
• MDR Text Key: 21837943
• Report Number: 8010762-2014-00337
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/17/2014,08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Model Number: 70105.3824
• Device Lot Number: 70097375
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2014
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2014
• Date Manufacturer Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention