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

Catalog Number 2C2063K

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 05/11/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address: (b)(6) e1: initial reporter postal code: (b)(6) 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 the bladder of a large volume infusor ruptured which resulted in a leak; further described as "the balloon within the bottle appears to have been leaking.The balloon is misshapen." the was identified toward the end of the 24 hour infusion period.The device was filled with vancomycin (viatris) 4000mg in sodium chloride 0.9%.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: device manufacture date: the lot was manufactured from december 1, 2022, to december 5, 2022.H10: the device was received for evaluation.A visual inspection noted that the bladder had been ruptured.The ruptured bladder was examined for signs of abnormality and there were none found on the bladder that may have led to the rupture.The reported condition was verified.The root cause could not be determined; however, a possible root cause for the bladder rupture may be due to inherent variation in the material as bladders are manufactured with rubber.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: 17086661
• MDR Text Key: 316807497
• Report Number: 1416980-2023-02796
• 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,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2063K
• Device Lot Number: 22N004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 07/04/2023
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SODIUM CHLORIDE 0.9%.; VANCOMYCIN (VIATRIS).