MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW RF32; CENTRIFUGAL PUMP

Catalog Number 70000.0987

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

It was reported that during startup for a hipec procedure (hyperthermic intraperitoneal chemotherapy), there was no flow to the circuit.The customer reported no rotation from the rotaflow.The system was checked for nicks or clamps.The rotaflow was then replaced.Thereafter, fluid passed w/o difficulty.Ref.: (b)(4).

Manufacturer Narrative

(b)(4).A supplemental medwatch will be submitted when add'l info becomes available.

• Brand Name: ROTAFLOW RF32
• Type of Device: CENTRIFUGAL PUMP
• 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 drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3695794
• MDR Text Key: 18573225
• Report Number: 8010762-2014-00027
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K991864
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/17/2014,12/18/2013

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: 01/11/2014
• Device Catalogue Number: 70000.0987
• Device Lot Number: 92091935
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/17/2014
• Device Age: 14 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/18/2013
• Initial Date FDA Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2012
• 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