MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HMOD70000-USA; DIFFUSIVE MEMBRANE OXYGENATOR

Model Number 70105.3515

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

The customer stated that there was presence of clot on the arterial side of the hmod70000 oxygenator during support.Cases was supported by veno-arterial cannulation.The customer stated that on a occasion the act (activated clotting time) was as low as 160 seconds during support.Additionally, the customer stated the post-cardiotomy cases were coagulopathic before support and clotting factors were given during the period support.Coagulation factors were given post-oxygenator according to the customer.The most recent supported case, it was suspected that clot was sent to the patient.No personal injury.(b)(4).Ref mfr 8010762-2014-00088.

• Brand Name: HMOD70000-USA
• Type of Device: DIFFUSIVE MEMBRANE OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 3674866
• MDR Text Key: 4256645
• Report Number: 3008355164-2014-00032
• Device Sequence Number: 1
• Product Code: DTZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2014,02/07/2014

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: 07/01/2015
• Device Model Number: 70105.3515
• Device Catalogue Number: HMOD70000-USA
• Device Lot Number: 70093196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/07/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 DA
• Patient Weight: 4