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

Catalog Number 2C2063K

Device Problem No Flow (2991)

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

Event Type  malfunction  

Manufacturer Narrative

B3: event date and d10: concomitant product therapy dates - the first device was connected (b)(6) 2024 and the second device was connected (b)(6) 2024.E1: initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was no fluid flow through two (2) large volume infusors.The first infusor was connected to the patient for therapy and the next day it was observed that the device had failed to deliver any of the medication dose.A second infusor was prepared for medication delivery to the patient, and it was observed again that there was no fluid flow through the device.The device contained 13500mg piperacillin / tazobactam in 0.9% sodium chloride (nacl).There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: h3, h4, h6, h11.H4: the lot was manufactured between july 25, 2023 and july 26, 2023.H11: the actual devices were not available; however, a photograph of a companion sample in a pouch was provided for evaluation.Visual inspection of the photograph did not identify any abnormalities that could have contributed to the reported condition.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: 19191825
• MDR Text Key: 341149949
• Report Number: 1416980-2024-01914
• 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: 05/30/2024

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: 23G029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• 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: NACL; PICC; PIPERACILLIN / TAZOBACTAM