MAUDE Adverse Event Report: INTERNATIONAL BIOPHYSICS CORPORATION FLOPUMP

Catalog Number	6000N
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	02/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded by the user and not returned for evaluation.The user stated that the product was not being used in a manner consistent with the instructions for use.The user stated that the product was used longer than six (6) hours which is considered off-label use for this device.
Event or Problem Description
Per customer information, the product caused high hemolysis in a patient.According to user, device was being used for extended period of time, longer than six (6) hours.

• Brand Name: FLOPUMP
• Common Device Name: FLOPUMP
• Manufacturer (Section D): INTERNATIONAL BIOPHYSICS CORPORATION; 2101 e. st. elmo road; suite 275; austin TX 78744
• MDR Report Key: 5695256
• Report Number: 1645362-2016-00003
• Device Sequence Number: 13463984
• Product Code: KFM
• UDI-Device Identifier: 00814321020001
• UDI-Public: 00814321020001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K983272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6000N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2016
• Initial Report FDA Received Date: 06/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other