MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INFUSOR; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2C1008K

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that one unit of an english-chinese infusor lv (large volume) had the ¿administration tube set cracked¿.This was identified prior to use on a patient.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, h3, h4 and h6: h4: the device was manufactured from september 3, 2019 - september 4, 2019.H10: the actual device was received for evaluation filled with fluid.A visual inspection performed using the naked eye found broken tubing at the junction of the white flow restrictor.A portion of the broken tubing remained inside the solvent-bonded area of the flow restrictor.The reported condition was verified.The cause of the condition could not be determined.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: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10730781
• MDR Text Key: 212968265
• Report Number: 1416980-2020-06608
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412022512
• UDI-Public: (01)00085412022512
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C1008K
• Device Lot Number: 19J021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1