MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY 01970110#QUADROX-I WITHOUT FILTER; MICROPOROUS MEMBRANE OXYGENATOR

Model Number 70103.1733

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 02/14/2014

Event Type  malfunction  

Event Description

It was reported that there was leakage on connector while priming.As they connect a stopcock, they have a leakage on ll.If they turn on the pump leakage increased.Ref #: (b)(4).

Manufacturer Narrative

(b)(4).The mfr has received the devices for investigation.The devices are under going laboratory investigation to determine the root-cause.A supplemental medwatch will follow once new info becomes available.

• Brand Name: 01970110#QUADROX-I WITHOUT FILTER
• Type of Device: MICROPOROUS MEMBRANE OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: janice pevide ; 45 arbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3831963
• MDR Text Key: 4392739
• Report Number: 8010762-2014-00123
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K090511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/07/2014,02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2014
• Device Model Number: 70103.1733
• Device Catalogue Number: 01970110#QUADROX-I
• Device Lot Number: 70093582
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/04/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/07/2014
• Device Age: 24 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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