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

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.

• Brand Name: INFUSOMAT® SPACE PUMP SETS WITH ULTRASITE® VALVE
• Type of Device: SPACE 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 Key: 5913977
• MDR Text Key: 54288628
• Report Number: 9614279-2016-00055
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/12/2014

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 Catalogue Number: 490036
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2014
• 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
• Patient Sequence Number: 1