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

Catalog Number 2C2120K

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a ce intermate lv (large volume) 100 ml would not flow.This was observed during an unspecified process step.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from(b)(6) , 2020- (b)(6) , 2020.H10: the device was received containing fluid inside the bladder.Visual inspection was performed using the naked which showed no evidence of fluid flow coming out at the distal luer.Additional force prime was performed; however, flow was not observed.When the tubing line was cut to drain fluid, fluid was observed coming out from the tubing that was cut which indicated that an excess of solvent bonding was applied at the solvent-bonded junction between the tubing and distal luer.The reported condition was verified.The cause of the condition was due to excess solvent applied on the tubing during manufacturing process.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: INTERMATE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12235908
• MDR Text Key: 263852497
• Report Number: 1416980-2021-04610
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412487922
• UDI-Public: (01)00085412487922
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2120K
• Device Lot Number: 20N020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.