MAUDE Adverse Event Report: INTERNATIONAL BIOPHYSICS CORPORATION FLOPUMP

Catalog Number	6000S (KIT)
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was returned and evaluated, it was determined that the product had a crack in the base along the shaft.
Event or Problem Description
Customer reported that when filling the priming circuit with physiological saline solution, verified a cracking in surface of the product.(no contact with the patient).

• 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: 6705729
• Report Number: 1645362-2017-00004
• Device Sequence Number: 16660661
• Product Code: KFM
• UDI-Device Identifier: 00814321020094
• UDI-Public: 00814321020094
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K983272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/11/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2018
• Device Catalogue Number: 6000S (KIT)
• Device Lot Number: 051016-4337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1