MAUDE Adverse Event Report: BAXTER HEALTHCARE - IRVINE I NFUSOR; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2C1063KP

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fever (1858); Septic Shock (2068); Chills (2191); Shaking/Tremors (2515)

Event Date 11/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Lot 15h026 was manufactured august 11, 2015 ¿ august 12, 2015.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was received for evaluation.Visual inspection on the returned unit noted approximately two milliliters of fluid inside the housing which indicated leakage had occurred.Further examination on the unit revealed the direct cause of leakage inside the housing was due to a ruptured bladder.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient's ce infusor leaked an unspecified antibiotic solution from the reservoir into the housing of the infusor and the patient subsequently experienced septic shock.The cause of the leak was a hole in the balloon.The septic shock was manifested by chills, rigors, fever, and feeling unwell.The cause of the septic shock was not reported.One day after noting the leak, the patient was admitted to the hospital and treated with another unspecified antibiotic and hydration.At the time of this report, the patient's condition was reported to be stable.No additional information is available.

• Brand Name: I NFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue, bldg 3; irvine CA 92614
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue, bldg 3; irvine CA 92614
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5278933
• MDR Text Key: 33070451
• Report Number: 1416980-2015-43813
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/09/2015

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: Pharmacist
• Device Catalogue Number: 2C1063KP
• Device Lot Number: 15H026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/09/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention