MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BEQ-QUADROX-ID OXYGENATOR; DIFFUSION MEMBRANE OXYGENATOR

Model Number 70105.3325

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

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

Event Date 07/04/2014

Event Type  malfunction  

Event Description

It was reported that methylene blue was utilized the first day of ecls (extra-corporeal life support) for "vasoplegia syndrome" in an attempt to improve blood pressure and central hemodynamics.Forty eight hours after use, the water bath was tinged blue.The venous blood color was also noted to be much darker, with some blue discoloration noted on the venous tubing.The patient was without fever and responding favorably to ecls therapy.The patient was successfully removed from support on day five.(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and corrective actions for the device described in this report.Based on the reported event and investigation, the reported event was caused by use that is beyond the usage described in our labeling and cleared intended use.A maquet territory manager explained to the clinician that methylene blue is contraindicated in the device ifu.He explained that methylene blue can cross the polyurethane heat exchanger and enter the water bath of the heat exchange device.Once in the water of the heat exchanger, methylene blue changes molecular configuration and cannot go back across the polyurethane heat exchanger back into the bloodstream.This occurs at a molecular and bacteriostatic level.This can alter the blood plasma level and concentration of the methylene blue for the patient.A supplemental medwatch will be submitted if additional information becomes available.

• Brand Name: BEQ-QUADROX-ID OXYGENATOR
• Type of Device: DIFFUSION MEMBRANE OXYGENATOR
• 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: 4223676
• MDR Text Key: 18094378
• Report Number: 8010762-2014-00278
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2014,07/11/2014

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 Expiration Date: 01/01/2014
• Device Model Number: 70105.3325
• Device Lot Number: 70091548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/11/2014
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2014
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2013
• 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 Age: 10 YR
• Patient Weight: 60