MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY QUADROX-I + HMO 70000+VHK7100; VKMO 70000 #QUADROX-I HMO 70000+VHK7100

Model Number 70106.4523

Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916)

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

Event Date 04/01/2014

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device (b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and corrective actions for the device described in this report.The production staff has been informed of the reported incident and retrained.Additional action will be taken under the internal capa procedure.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the sterile bag containing the oxygenator and reservoir was not sealed.(b)(4).

• Brand Name: QUADROX-I + HMO 70000+VHK7100
• Type of Device: VKMO 70000 #QUADROX-I HMO 70000+VHK7100
• Manufacturer (Section D): MAQUET CARDIOPULMONARY; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 38; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3915324
• MDR Text Key: 19398895
• Report Number: 8010762-2014-00211
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K102919
• 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: 05/27/2014,04/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2015
• Device Model Number: 70106.4523
• Device Lot Number: 92122195
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/26/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2013
• 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