MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG VKMO 70000#QUADROX-I HMO 70000+VHK 2001; OXYGENATOR + VENOUS HARDCOVER RESERVOIR

Model Number VKMO 70000

Device Problems Inadequate Filtration Process (2308); Filtration Problem (2941)

Patient Problem Injury (2348)

Event Date 01/09/2014

Event Type  Injury  

Event Description

It was reported that a quadrox oxygenator with a venous reservoir was being used in an emergency dissection case.Air developed in the reservoir after three hours of use.Air volume was grade 6 (in terms of 10) because bubbles had appeared from the reservoir filter and dropped.During the six hour procedure the reservoir filled with bubbles.For the sake of pt safety, the oxygenator could not be changed.The pt's condition was reported to be good at the time of the reported incident.(b)(4).

Manufacturer Narrative

(b)(4).Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.An investigation of the returned sample was performed.Manufacturing records were reviewed and no deviations were found.All the filters inside the reservoir were located and attached correctly.The filter/defoamer material was not damaged.A clot was found in the defoamer which could have formed after the contaminated reservoir dried, since the customer did not report any clots.The investigation also ruled out incorrect assembly and reservoir damage.A pt injury was not disclosed until (b)(6) 2014.

• Brand Name: VKMO 70000#QUADROX-I HMO 70000+VHK 2001
• Type of Device: OXYGENATOR + VENOUS HARDCOVER RESERVOIR
• 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: 3645293
• MDR Text Key: 20295395
• Report Number: 8010762-2014-00054
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/14/2014,01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2015
• Device Model Number: VKMO 70000
• Device Catalogue Number: 70103.2230
• Device Lot Number: 70087532
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/14/2014
• Device Age: 11 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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): Other