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

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the filter of non-dehp extension set was leaking.The leak was discovered during patient infusion and was the size of droplets.The nurses were assessed for method of operation and it was found they were not priming correctly (did not invert and tap filter when priming).The issue was resolved by replacing the affected set.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

It was reported that the filters of an unknown number of non-dehp extension sets were leaking (reported as one unit on initial).\ although the lot numbers were unknown, the customer reported 5 potential lot numbers; dr17j18037, dr17e03053, dr17k28059, dr17l13083 and dr18a13084.A batch review was performed for all of the potential lot numbers and there were no deviations found related to this reported condition during the manufacture of this lot.Two used samples were received for evaluation.Visual inspection was performed using the naked eye.All components were correctly placed and according to specifications (no visual defects were observed).The samples were then functionally tested.When the samples were primed, the samples flowed normally, however, leaks were observed in the air vents of the filters.The reported condition was verified.The cause of the condition could not be determined.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: 7621965
• MDR Text Key: 111874508
• Report Number: 1416980-2018-03747
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

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 Catalogue Number: 2N3350
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 07/05/2018
• Supplement Dates FDA Received: 07/24/2018
• 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: N
• Patient Sequence Number: 1