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

Catalog Number 2C1073KJP

Device Problem Filling Problem (1233)

Patient Problems Swelling (2091); No Consequences Or Impact To Patient (2199)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a half day infusor underinfused.The device was filled with desferrioxamine 450mg in 50ml sodium chloride 0.9%.It was further reported that the there was still product left in the balloon.There was no patient injury or medical intervention associated with this event, however the patient reported stinging at the site and swelling.No additional information is available.

Manufacturer Narrative

Additional information was added: the lot was manufactured between march 22, 2018 to march 29, 2018.The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed including a functional flow rate test and the results were found to be within the product specification range.The reported condition was not verified.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
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9823963
• MDR Text Key: 183121438
• Report Number: 1416980-2020-01365
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081663
• UDI-Public: (01)00085412081663
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C1073KJP
• Device Lot Number: 18C037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2020
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: 450MG DESFERRIOXAMINE; 50ML SODIUM CHLORIDE 0.9%
• Patient Age: 24 MO