MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD 2000 ML TPN BAG; PUMP, INFUSION

Catalog Number H938740

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that six (6) units of 2000ml eva tpn bags had burst.This event occurred during preparation of the device.It was further reported that one of the bags had burst and emptied onto the customer's hepa filter.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Three (3) devices were returned for evaluation.A visual inspection was performed and it was noted that one sample had a large tear at the top middle section of the bag along the top weld and the other two samples leaked from the spike port tubing cap.Functional testing was performed and it was noted that all three samples were leaking.The reported conditions were verified.The cause of the reported conditions could not be determined.This issue is being further investigated.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.

• Brand Name: 2000 ML TPN BAG
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - ENGLEWOOD; englewood CO
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7400724
• MDR Text Key: 104550850
• Report Number: 1416980-2018-01888
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477244
• UDI-Public: (01)00085412477244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

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: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: H938740
• Device Lot Number: 60070832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 05/09/2018
• 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