MAUDE Adverse Event Report: INTERNATIONAL BIOPHYSICS CORPORATION FLOPUMP

Catalog Number	6000S(KIT)
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2016
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
Per customer complaint report, the flopump contained cracks on the base of the product.The crack was noticed during priming of the pump and the device was not used with the patient at all.

• 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: 6322604
• Report Number: 1645362-2017-00001
• Device Sequence Number: 10931657
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/09/2017

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: 10/30/2017
• Device Catalogue Number: 6000S(KIT)
• Device Lot Number: 103015-3833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 02/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1