MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG 01971110#QUADROX-I + FILTEREINHEIT; MICROPOROUS MEMBRANE OXYGENATOR

Model Number 70103.1736

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

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

Event Date 05/28/2014

Event Type  malfunction  

Event Description

It was reported that during priming, leakage and a crack were observed in the device.Ref: # (b)(4).

Manufacturer Narrative

(b)(4).The device was received with cracks at the de-airing luer lock port.The device was tested for leakage, and leakage was confirmed.A review of the device history record shows the device passed the final 100% test with no deviations or abnormalities noted.A review of the quality control process indicated that 100% visual inspection for cracks was performed during the final control process.The device passed the final inspection with no deviations or abnormalities noted.Info obtained confirms the device met specification during production.The cause of the event could not be determined.A supplemental medwatch will be submitted if additional info becomes available.

• Brand Name: 01971110#QUADROX-I + FILTEREINHEIT
• 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 krebs ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097359
• MDR Report Key: 4102551
• MDR Text Key: 20270518
• Report Number: 8010762-2014-00328
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132829
• 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: 08/27/2014,08/01/2014

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: 09/01/2015
• Device Model Number: 70103.1736
• Device Lot Number: 70094120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/22/2014
• Device Age: 11 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/01/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2013
• 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