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

Catalog Number 2C2008K

Device Problems Filling Problem (1233); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fever (1858); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/14/2024

Event Type  Injury  

Event Description

It was reported a large volume infusor over infused 5-fluorouracil (5-fu).The expected infusion time was ninety-six hours; however, the infusion completed after approximately six and half hours.The following day the patient experienced unspecified symptoms of potential toxicity of 5-fu and febrile neutropenia.The patient was hospitalized and received an unspecified ¿antidote¿ for 5-fu.The patient was discharged from the hospital seven days after admission.Follow-up information indicated that the total fill volume of the 5-fu was 192 ml.Per the product label, the nominal fill volume should be 240 ml and the minimum fill volume should be 216 ml.Filling the device with less than the minimum fill volume will result in increases in flow rate and reductions in delivery time (over infusion).No further information was available at the time of this report.

Manufacturer Narrative

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

Manufacturer Narrative

H4: the lot was manufactured between july 12, 2023 - july 15, 2023.H10: the device was received for evaluation.A functional flow rate test was performed, and it was confirmed that an overinfusion occurred.Airflow and bladder pressure tests were performed, and it was noted that the air flow failed the test (as expected, due to a pinched large o-ring inside the restrictor housing).The bladder pressure was found to be within specification.Measured dimensions of relevant components (flow restrictor, small and large o-rings, capillary glass) from the complaint sample, and the measurement results were found to be within specification.Measured elasticity (hardness) of o-rings from the complaint sample, and the elasticity of the o-rings from the complaint sample was found to be the same as the o-rings from a control sample, therefore, no issue was found.The reported condition was verified.The cause of the overinfusion was due to a pinched large o-ring located inside the flow restrictor housing (a manufacturing issue).Since the large o-ring was pinched, fluid was able to bypass the capillary glass (restrictor) located inside the restrictor housing and resulted in a fast flow (overinfusion).A nonconformance has been opened to address this issue.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: 19085443
• MDR Text Key: 339876262
• Report Number: 1416980-2024-01649
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412579382
• UDI-Public: (01)00085412579382
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2008K
• Device Lot Number: 23G022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/10/2024
• 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: 5-FLUOROURACIL
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male