MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 2000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938740

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: this event occurred on an unspecified date in (b)(6) 2019.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that micro bubbles were coming from the bag spike area of an unspecified quantity of exactamix 2000 ml eva tpn bags.It was further reported that the bubbles were so small they were hard to ¿flick¿ together to be able to prime them out.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The lot number was manufactured between august 06, 2018 - august 07, 2018.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device(s) were 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: 2000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE ¿ ROUND LAKE; round lake IL
• MDR Report Key: 8325692
• MDR Text Key: 135719203
• Report Number: 1416980-2019-00712
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477244
• UDI-Public: (01)00085412477244
• Combination Product (y/n): N
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: H938740
• Device Lot Number: 60140578
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1