MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. INFUSOMAT® SPACE PUMP SETS; INFUSOMAT SPACE PUMP Y-TYPE BLOOD SET

Catalog Number 490043

Device Problems Air Leak (1008); No Audible Alarm (1019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.(b)(4).One used space pump y-type blood set, without packaging, was received for evaluation.The distal end of the set was connected to a stopcock and safeday set.In an attempt to replicate the reported event, the returned set was spiked, primed, and loaded into an infusomat space pump as per the instructions for use.The pump rate was set at 325 ml/hr and the set ran for approximately 30 minutes.During this time, there were no air bubbles observed in any location of the tubing set.Furthermore, the set was subjected to occlusion and air pressure (leakage) tests 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 set met requirements according to specification, and the reported failure could not be reproduced.Based on the event scenario given by the reporting facility, the infusion was completed and the pump did alarm for "infusion complete." it was indicated that the air in the line was observed upstream of the pump and did not reach the pump segment.There was no air observed after the pump segment or near the patient.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 by the end of the infusion, air was in the line full way down the set.The pump did not alarm.There was no patient injury.Per follow-up correspondence with the reporter, it was clarified that the tubing line was still in the pump when the blood was completely infused.The saline line of the y tubing was clamped; only the blood bag was open.The air was noticed after the blood infusion was completed and the pump alarmed 'infusion completed.' air was then being pulled in by the pump from the empty blood filter bag.The air in the line was noted between the filter and the pump right before the pump segment.When the air was noticed, the pump was shut off.The customer clarified that the air was not anywhere near the patient.

• Brand Name: INFUSOMAT® SPACE PUMP SETS
• Type of Device: INFUSOMAT SPACE PUMP Y-TYPE BLOOD SET
• 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: 5762622
• MDR Text Key: 49388567
• Report Number: 9614279-2016-00044
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 490043
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2016
• 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