• 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 SAFELINE® SPACE PUMP SET WITH SAFELINE INJECTION SITE

  • 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 SAFELINE® SPACE PUMP SET WITH SAFELINE INJECTION SITE Back to Search Results
Catalog Number 362032
Device Problem Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2013
Event Type  malfunction  
Manufacturer Narrative
(b)(4). One (1) used space pump iv tubing set, and two (2) unused, unopened sets (in packaging indicating the reported lot number 0061255803) were received for evaluation. In an attempt to replicate the reported incident, all three sets were spiked to a bag of normal saline and primed. The roller clamp was then closed and re-opened several times. Each time the roller clamp was closed, the set was allowed to hang for several minutes. During each test, the roller clamp functioned properly and no leakage was observed. Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number. 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. If additional pertinent information becomes available, a follow-up report will be filed.
 
Event Description
As reported by the user facility: event # 2: reports the wheel in the roller clamp appears to be loose to the point that it does not completely restrict fluid flow through the tubing. There was no patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINFUSOMAT® SPACE PUMP SETS WITH SAFELINE®
Type of DeviceSPACE PUMP SET WITH SAFELINE INJECTION SITE
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 Key5646458
MDR Text Key45651768
Report Number9614279-2016-00020
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K062700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 08/30/2013
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Catalogue Number362032
Device Lot Number0061255803
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2013
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-