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

Catalog Number 490102

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One used space pump iv tubing set, without packaging, was received for evaluation.In an attempt to replicate the reported event, the returned set was primed with a normal saline solution and loaded into an infusomat space pump as per the instructions for use.The pump rate was set at 325 ml/hr and the sets ran for approximately 20 minutes.During this time, there were no air bubbles observed in any location of the tubing set and the pump did not alarm any errors.Furthermore, the set was subjected to an air pressure (leakage) test according to specification with acceptable results.There were no leakages observed.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned set met requirements according to specification, and the reported failure could not be reproduced.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.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports air bubbles were coming through the blue filter above the port upstream from the pump.

• Brand Name: INFUSOMAT® SPACE PUMP SETS WITH CARESITE® VALVE
• Type of Device: SPACE PUMP IV SET WITH CARESITE 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 Key: 5913974
• MDR Text Key: 54286903
• Report Number: 9614279-2016-00058
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K062700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2018
• Device Catalogue Number: 490102
• Device Lot Number: 0061453846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2015
• 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