MAUDE Adverse Event Report: B. BRAUN OF DOMINICAN REPUBLIC INFUSOMAT SPACE PUMP SET WITH CARESITE; UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV

Catalog Number 363421

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2014

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report (b)(4).The actual device involved in the reported incident was not returned for evaluation.Review of the discrepancy management system database performed for the reported lot number revealed a discrepancy report issued in which one part was found with leakage between the bonded joint of the backcheck valve and caresite valve during in-process testing.A total of (b)(4) units were segregated and re-tested at the time of manufacture.The root cause was attributed to an incorrect assembly method in which insufficient solvent was applied and the backcheck valve was not properly rotated and inserted into the caresite valve.Subsequently, corrective actions have been taken to ensure the root cause has been addressed.The complaint event did not specify where the reported set leaked and there is no other info available to suggest that the aforementioned discrepancy contributed to the reported event or that they are related.Without the actual sample, a thorough evaluation could not be performed and no specific conclusions can be drawn.If additional pertinent info becomes available, a follow-up report will be filed.

• Brand Name: INFUSOMAT SPACE PUMP SET WITH CARESITE
• Type of Device: UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV
• Manufacturer (Section D): B. BRAUN OF DOMINICAN REPUBLIC; santo domingo ; DR
• Manufacturer Contact: felipe sandoval ; km. 22 autopista las americas; las americas industrial park; santo domingo ; DR ; 5491000
• MDR Report Key: 3692861
• MDR Text Key: 4293778
• Report Number: 9614279-2014-00004
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/04/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 363421
• Device Lot Number: 0061335684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2014
• Initial Date FDA Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR