MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-I ADULT + FILTER; MICROPOROUS MEMBRANE OXYGENATOR

Model Number 70103.1736

Device Problems Partial Blockage (1065); Occlusion Within Device (1423); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2014

Event Type  malfunction  

Event Description

It was reported there was clotting in an oxygenator.Problems were also experienced priming the heart lung unit.Act value was over 350.Cold antibodies played no role, as this was driven under normal body temperature.(b)(6).

Manufacturer Narrative

Maquet med systems, usa submits this report on behalf of the legal mfr of the device maquet cardiopulmonary (b)(4).(b)(4) provides product failure investigation, analysis and corrective actions for the device described in this report.A supplemental medwatch will be submitted if additional info becomes available.

• Brand Name: QUADROX-I ADULT + FILTER
• Type of Device: MICROPOROUS 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 dr; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3902824
• MDR Text Key: 4542020
• Report Number: 8010762-2014-00060
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K100278
• 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
• Type of Report: Initial
• Report Date: 02/20/2014,01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2014
• Device Model Number: 70103.1736
• Device Catalogue Number: 01970110#QUADROX-I
• Device Lot Number: 70094121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2014
• Device Age: 20 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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