MAUDE Adverse Event Report: B. BRAUN OF DOMINICAN REPUBLIC INFUSOMAT SPACE PUMP SETS WITH CARESITE; SPACE PUMP IV SET W/ 2 CARESITES AND ASV

Catalog Number 363420

Device Problems Fluid/Blood Leak (1250); Use of Device Problem (1670); Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

As reported by the user facility: reports there was a chemotherapy spill that was a result of the vent cap popping out of the spike.The nurse was hanging paclitaxel, which is in one of the rigid non-pvc iv bags, and was under the impression the vent needed to be opened.As the nurse opened the vent the entire vent cap popped out of the spike which resulted in chemotherapy spilling out from the spike.The reporter stated that while reviewing the incident with pharmacy, they took a clean tubing set to try to duplicate what had happened.The reporter stated they were able to duplicate the event in that "the whole vent cap popped out without a lot of trouble." the reporter indicated that it was reviewed with the chemo nurse that the vent only needed to be used with glass bottles.However, the facility is concerned that the vent cap was able to be removed so easily.

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.However, the facility returned two unused sets from their current inventory (from catalog # 363421 with packaging indicating lot #'s 0061353560 and 0061349803, respectively).Catalog # 363421 contains a similar drip chamber spike with air vent as the reported catalog # 363420.The returned sets were subjected to an air pressure (leakage) test according to specification with acceptable results.There were no leakages observed and the air vents did not open or pop off during the testing time frame.An attempt was then made to manually remove the air vents.The air vents were able to be removed from the drip chamber spike assembly using excessive force.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature noted during in-process or final product inspection.All available information has been forwarded to the device manufacturer of the drip chamber spike.Following the receipt of additional information and/or completion of the investigation by the vendor, a follow-up report will be filed.

• Brand Name: INFUSOMAT SPACE PUMP SETS WITH CARESITE
• Type of Device: SPACE PUMP IV SET W/ 2 CARESITES AND ASV
• Manufacturer (Section D): B. BRAUN OF DOMINICAN REPUBLIC; santo domingo ; DR
• Manufacturer Contact: felipe sandoval ; las americas industrial park; km22 autopista las americas; santo domingo ; DR ; 5491000
• MDR Report Key: 3881554
• MDR Text Key: 4567780
• Report Number: 9614279-2014-00026
• 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 Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 363420
• Device Lot Number: 0061341759
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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