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

Catalog Number 2N3350

Device Problems Failure to Prime (1492); Reflux within Device (1522)

Patient Problem No Patient Involvement (2645)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a non-dehp micro-volume extension set 60" would not prime resulting in fluid back up and occlusion alarms on an unspecified pump.The patient was not connected at the time of the events.The nurse reported that ¿the new syringe and tubing were primed and set up on the pump.The medication/fluid carrier was being allowed to mix in the tubing prior to patient connection.All connections were checked and secured and fluids were visualized dripping from the end of the line at the correct rate.After approximately one hour, the pump read an occlusion in the line and a back up of fluid was found behind one of the connection sites.The tubing was re-primed and again fluid was visualized dripping at the end of the line at the correct rate.After another approximate 45 minutes of mixing, another occlusion was read on the pump and a backup of fluid was found behind a connection.¿ this issue was identified during set up and preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed on the photograph with no issues noted.By the nature of the sample, no additional tests were performed.The reported condition was not verified.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: 9082444
• MDR Text Key: 159196690
• Report Number: 1416980-2019-05105
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: No
• 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