MAUDE Adverse Event Report: DATASCOPE CORP. ECC 3/8" PACK; CARDIOPULMONARY DEVICE

Model Number BEQ-TOP-33700

Device Problem Malfunction (2409)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2014

Event Type  malfunction  

Event Description

The pt had been given methaline blue, which is contraindicated for quadrox id, prior to going on ecls.The respiratory therapist noticed the tempered water going through the water lines to the heather cooler had a slight blue color.The pt came off ecls successfully, with no reported adverse events.

Manufacturer Narrative

No device was returned, therefore no eval was performed to confirm the reported problem.Based on the description of the event, the facility used "methaline" blue on the pt just prior to initiating therapy with this device.The instructions for use state in section 4, warnings and precautions; "when using the oxygenator, methylene blue must not be administered immediately before or during perfusion." the use of methaline blue affects the permeability of the membrane fibers in the oxygenator which could lead to negative consequences for the pt.Device history records do not indicate any non-conformances related to this event.If the product is returned or add'l info received, a supplemental report will be submitted.(b)(4).

• Brand Name: ECC 3/8" PACK
• Type of Device: CARDIOPULMONARY DEVICE
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ
• Manufacturer Contact: jason sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3895976
• MDR Text Key: 4541030
• Report Number: 2248146-2014-00078
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080592
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: BEQ-TOP-33700
• Device Catalogue Number: 701053845
• Device Lot Number: 16358-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 23 YR