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

Catalog Number 2C2063K

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that five (5) large volume infusors had leakage; further described as "the connection area is damaged".This issue was discovered prior to patient use, when the devices were delivered.The leaks were contained within the sealed overpouches; however, there was no damage observed to the overpouches or the carton the product was delivered in.The devices were filled with benzylpenicillin 10800mg in 240ml sodium chloride 0.9%.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from october 25, 2022 - october 26, 2022.H10: the actual device was not available; however, a photograph of the samples was provided for evaluation.The photo showed images of fluid inside a green color bag that contained the devices, which suggested a leak occurred.There was no evidence of damage to the device connection areas shown in the photograph.The reported condition was verified.The cause of the condition could not be determined by the photographs.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: 16455433
• MDR Text Key: 310380879
• Report Number: 1416980-2023-00733
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412579412
• UDI-Public: (01)00085412579412
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2063K
• Device Lot Number: 22K027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NA.