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

Catalog Number 2C1009KP

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an infusor lv (large volume) leaked; further described as ¿the injection tube of the tube of the solution was ripped¿.This was identified prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the actual device was received for evaluation.A visual inspection performed using the naked eye found a pinched mark located on a segment of the tubing line.The device was leak tested and a leak was observed from the pinched mark area.The reported condition was verified.The cause of the condition is related to a manufacturing issue.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: 10272075
• MDR Text Key: 198754961
• Report Number: 1416980-2020-03992
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081373
• UDI-Public: (01)00085412081373
• Combination Product (y/n): Y
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C1009KP
• Device Lot Number: 19N018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1