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

Catalog Number 490100

Device Problems Air Leak (1008); False Alarm (1013); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).One used space pump set, with packaging identifying the reported lot number 0061316407, was received for evaluation.The set was spiked into a baxter pab bag of magnesium sulfate in 0.9% sodium chloride solution.The returned set was loaded into an infusomat space pump and primed on the pump with the remaining solution from the returned pab bag.The pump rate was set at 325 ml/hr.All remaining fluid from the pab bag then ran through the set without any alarms or air bubbles observed.Next, the set was manually primed with a normal saline solution and loaded into an infusomat space pump as per the instructions for use.The pump was set at the same rate and allowed to run for 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 occlusion and air pressure (leakage) tests according to specification with acceptable results.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.There were no other reports of this nature against the reported lot number.Based on the results of this investigation, no conclusions can be made regarding the cause of the reported event.The returned sample met requirements according to specification.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports air in the tubing line above the pump.Details of how the set was primed are unknown.A follow-up phone conversation with the reporting facility regarding this incident indicated that the air in line was experienced during administration of epinephrine to the patient.The pump alarmed three different errors (air in line; accumulated air in line; and occlusion) during administration.Although one of the alarms was for occlusion, there was no occlusion confirmed.

• Brand Name: INFUSOMAT® SPACE PUMP SETS WITH CARESITE®
• Type of Device: SPACE PUMP IV 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: 5361207
• MDR Text Key: 36248987
• Report Number: 9614279-2015-00074
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/14/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 490100
• Device Lot Number: 0061316407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2013
• 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