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	11/16/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump was investigated upon return per (b)(4).Based on the results of the investigation, it was concluded that the bearings of the pump were affected by the presence of blood within the bearings.The cause for this is not known, however, it is possible that the pump was damaged during shipping/transport/priming.It is also possible that the shaft of the pump was wobbling due to small cracks which were evidenced in the plastic base, which could have led to leaking into the bearing area.
Event or Problem Description
Per customer complaint report, the flopump evidenced an unusual noise and lack of minimal rotation and required replacement during procedure.The customer complaint was received by ibc on (b)(6) 2016.

• 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: 5410359
• Report Number: 1645362-2016-00001
• Device Sequence Number: 453170
• 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: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/04/2016

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: 11/20/2016
• Device Catalogue Number: 6000S(KIT)
• Device Lot Number: 112014-3281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2016
• Initial Report FDA Received Date: 02/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1