• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. INFUSOMAT® SPACE PUMP SETS WITH ULTRASITE® VALVE SPACE PUMP IV SET WITH ULTRASITE VALVE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

B. BRAUN DOMINICAN REPUBLIC INC. INFUSOMAT® SPACE PUMP SETS WITH ULTRASITE® VALVE SPACE PUMP IV SET WITH ULTRASITE VALVE Back to Search Results
Catalog Number 490036
Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2014
Event Type  malfunction  
Manufacturer Narrative
(b)(4). One used space pump iv tubing set, without packaging, was received for evaluation. The proximal ultrasite valve was connected to a phaseal adapter, which was piggybacked into a secondary iv set. The pump set was received spiked into a hospira 250ml pab bag of 0. 9% sodium chloride, with approximately 200ml of solution remaining in the bag. The secondary set was spiked into an empty b. Braun pab bag. The sets were visually examined and there was a section (approximately 18 inches) of air observed directly below the pump segment in the primary set, and other air bubbles of varying size observed throughout the secondary set. In an attempt to replicate the reported event, the returned sets were primed with normal saline, and loaded into an infusomat space pump as per the instructions for use. There were no air bubbles observed within the tubing lines while the set was running in the pump, and the pump did not alarm any errors. Furthermore, the sets were subjected to air pressure (leakage) testing according to specification with acceptable results. Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event. The returned sample met requirements according to specification, and the reported failure could not be reproduced. Given the returned set was received with air below the pump segment and no fluid remaining in the secondary bag, a potential cause appears to be that the secondary bag ran empty resulting in the air in the tubing and pump alarm. If the primary line is clamped off, then air will draw into the line from the empty secondary bag. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number. Without the lot number, a thorough batch record review could not be performed. If additional pertinent information becomes available, a follow-up report will be filed.
 
Event Description
As reported by the user facility: reports that air entered the line below the drip chamber, but there was still fluid in the bag and drip chamber. Approximately 18 inches of tubing had air in the line below the pump segment. The pump did eventually alarm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINFUSOMAT® SPACE PUMP SETS WITH ULTRASITE® VALVE
Type of DeviceSPACE PUMP IV SET WITH ULTRASITE VALVE
Manufacturer (Section D)
B. BRAUN DOMINICAN REPUBLIC INC.
las americas industrial park
km22 autopista las americas
santo domingo, dominican republic
DR
Manufacturer Contact
eric roden
las americas industrial park
km22 autopista las americas
santo domingo, dominican republic 
DR  
5491000
MDR Report Key5913977
MDR Text Key54288628
Report Number9614279-2016-00055
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/12/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number490036
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-