MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO ACCESS; FILTER, INFUSION LINE

Catalog Number 2N3342

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 02/25/2015

Event Type  Injury  

Event Description

It was reported that the tubing of a three lead extension set separated from the y-site closest to the patient end and leaked blood.It was reported that the patient lost approximately 5ml of blood and that blood backed up into the umbilical venous catheter.This occurred during infusion of total parenteral nutrition with a non-baxter pump.The patient was hospitalized for an unreported indication.Treatment for this event was a 10ml/kg bolus of normal saline.The patient has recovered and was discharged from the hospital.No additional information is available.

Manufacturer Narrative

(b)(4).(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was received for evaluation.Visual inspection showed that the tubing had separated from the first bifurcated y site outlet port.Microscopic inspection revealed that tool markings around the tubing near the solvent connection point.Additionally, a lack of solvent plow ridge was noted on the end of the tubing.The remaining solvent bonds received the pull test, passing successfully with no issues noted.Therefore, the reported condition was verified.The cause of the condition could not be determined.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4718223
• MDR Text Key: 5747962
• Report Number: 1416980-2015-18479
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2N3342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: PLUM A+ SMART PUMP, TOTAL PARENTERAL NUTRITION
• Patient Outcome(s): Required Intervention
• Patient Age: 3 DA