MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE

Catalog Number 2N3350

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The events occurred during unspecified dates in (b)(6) 2019.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified quantity of non-dehp micro-volume extension sets leaked from the junction at the filter.It was further reported as "leaking seemed to occur around the vent on the filter".This was identified during infusions of mycophenolate mofetil (mmf), promethazine, and hydrocortisone.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: during follow up it was reported, "2-3 baxter ¿bifuse connectors are daisy chained together¿ and set up with a non-baxter syringe pump.A one (1) ml syringe is in the syringe pump (non-baxter).The pump ¿is not able to display pressure, unknown if exceeding 45 psi¿.Leaking most often occurred with ¿one patient¿s mycophenalate, phenergan, petamidime medications.The leak most often occurred from the vent area¿.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MICRO-VOLUME EXTENSION SET
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9111321
• MDR Text Key: 159887688
• Report Number: 1416980-2019-05226
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2N3350
• Device Lot Number: DR19E03028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: HYDROCORTISONE; MYCOPHENOLATE MOFETIL (MMF); PHENERGAN (PROMETHAZINE)