MAUDE Adverse Event Report: DATASCOPE CORP. (MAQUET) ADULT CPS QID W/ROTAFLOW; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BEQ-TOP 38300

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371); No Flow (2991)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/01/2017

Event Type  malfunction  

Event Description

A stopcock on the patient inflow line of the extracorporeal membrane oxygenation (ecmo) circuit connects a bridge between the inflow and outflow lines.This stopcock, either through circuit manipulation or defect came loose, and ultimately disconnected causing hemorrhage and a ceasing of the ecmo circuit flow for several minutes.

• Brand Name: ADULT CPS QID W/ROTAFLOW
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DATASCOPE CORP. (MAQUET); 15 law dr; fairfield NJ 07004
• MDR Report Key: 6773304
• MDR Text Key: 82029446
• Report Number: 6773304
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: BEQ-TOP 38300
• Device Catalogue Number: 701055862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 4 YR