MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BMU 40 BLOOD MONITORING UNIT; BMU40

Model Number 70104.0852

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2014

Event Type  malfunction  

Event Description

It was reported that during support of a patient on extracorporeal life support, the blood monitoring unit blood values / parameters stopped being displayed.The unit was turned off and back on, but no values were displayed.The device had been in use continuously for 23 days of support.No patient effect reported.(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.It was reported that the serial # of the arterial sensor and venous cell were discarded by the customer.A supplemental medwatch will be submitted if additional information becomes available.

• Brand Name: BMU 40 BLOOD MONITORING UNIT
• Type of Device: BMU40
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: janice pevide ; 45 barbour pond dr; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3810771
• MDR Text Key: 4369327
• Report Number: 8010762-2014-00149
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2014,02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70104.0852
• Device Catalogue Number: 70104.0852
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2014
• Initial Date Manufacturer Received: 02/21/2014
• Initial Date FDA Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1