MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE

Catalog Number 2N3350

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a micro-volume extension set cracked and leaked during infusion.This occurred after 72 hours of infusion of total parenteral nutrition (tpn) in the neonatal intensive care unit (nicu).The set was used with a non-baxter infusion pump.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Complaint no: (b)(4).The device was not returned, therefore, a device analysis could not be completed.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Complaint no: (b)(4).Additional information: d10, h3, h6 (m3323 was replaced with m10, m38, and m26.R3221 was replaced with r114.C92 was replaced with c19).The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Pressure testing revealed a leak from the vent hole of the filter.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 - HAINA, SAN CRISTOBAL; parque industrial itabo, zona; haina ; DR
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL; parque industrial itabo, zona; haina ; DR
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5490213
• MDR Text Key: 40022199
• Report Number: 1416980-2016-04845
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 2N3350
• Device Lot Number: DR15114062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SMITH MEDICAL INFUSION PUMP, TPN