MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE; HCU30-100-120V

Model Number 701034371

Device Problems Misconnection (1399); Use of Device Problem (1670); Misassembly by Users (3133)

Patient Problem Ventricular Fibrillation (2130)

Event Date 12/10/2013

Event Type  Injury  

Event Description

It was reported that the water lines on the cardioplegia side of the hcu30 were inadvertently placed on the hls set.When the pt was placed on support the pt was inadvertently cooled which resulted in fibrillating the pt.The pt was resuscitated and the corrected lines were placed correctly on the hls set.The pt was then rewarmed.(b)(4).Please refer mfr report # 8010762-2014-00013.

• Brand Name: MAQUET HCU30 DEVICE
• Type of Device: HCU30-100-120V
• 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: 3599133
• MDR Text Key: 21110770
• Report Number: 3008355164-2014-00007
• Device Sequence Number: 1
• Product Code: DWC
• 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: 01/09/2014,12/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701034371
• Device Catalogue Number: 701034371
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/10/2013
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention