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

Catalog Number 363421

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Two used space pump iv tubing sets, without packaging, were received for evaluation.The sets were received spiked into fenwal 1000ml bags of anit-coagulate citrate dextrose solution.In an attempt to replicate the reported event, the returned sets were primed with the returned solution bags, 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 30 minutes.During this time, there were no air bubbles observed in any location of the tubing sets and the pump did not alarm any errors.Furthermore, both sets were 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 or lot number.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned sets met requirements according to specification, and the reported failure could not be reproduced.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: event # 2: reports air in the tubing line.The tubing had to be changed out three times.Per follow-up correspondence with the reporter, micro air emboli formed in the tubing and frequent 'air in line' and 'air accumulated' alarms occurred on the pump.The medication was not infusing correctly and the tubing, pumps, and bags were changed out three different times on shift.The medication infusing was an anticoagulant citrate dextrose solution.There was a delay in medication administration, but no harm to the patient.

• Brand Name: INFUSOMAT® SPACE PUMP IV ADMINISTRATION SET
• 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: 5792219
• MDR Text Key: 50231894
• Report Number: 9614279-2016-00049
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2019
• Device Catalogue Number: 363421
• Device Lot Number: 00VL495681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• 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