MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HMOD 70000-QUADROX-ID ADULT 0.FILTE; DIFFUSION MEMBRANE OXYGENATOR

Model Number HMOD 70000

Device Problems Loss of or Failure to Bond (1068); Out-Of-Box Failure (2311)

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

Event Date 08/05/2014

Event Type  malfunction  

Event Description

It was reported that when the customer removed the device from the box and tried to remove the outlet cap, the outlet came off.The outlet was described as looking cloudy.No pt involvement.(b)(4).

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device, maquet cardiopulmonary (b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.The device has not yet been received for eval.A supplemental medwatch will be submitted when additional info becomes available.

• Brand Name: HMOD 70000-QUADROX-ID ADULT 0.FILTE
• Type of Device: DIFFUSION 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: 4099237
• MDR Text Key: 19402345
• Report Number: 8010762-2014-00299
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101153
• 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
• Type of Report: Initial
• Report Date: 09/03/2014,08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Model Number: HMOD 70000
• Device Catalogue Number: 70105.3815
• Device Lot Number: 70097156
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/05/2014
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2014
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• 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