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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Nausea (1970); Vomiting (2144); Lethargy (2560); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

Age at time of event: the patient age ranges from 21 years old to 75 years old with a median age of 55 years.Gender: seven males and 10 females.Literature article: kerr, d.J., young a.M., neoptolemos, j.P., sherman, m., van-geene, p., stanley, a., ferr, d., dobbie, j.W., vincke, b., gilbert, j., el eini, d., dombros, n.And fountzilas, g."prolonged intraperitoneal infusion of 5-fluorouracil using a novel carrier solution".British journal of cancer (1996) 74, 2032-2035.Doi: 10.1038/bjc.1996.672.The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported 17 patients underwent a study in which unknown elastomeric infusor devices were used for intraperitoneal infusion of 5-fluorouracil (5-fu) over 24 hours for peritoneal carcinomas.It was reported that three patients experienced nausea and vomiting, two patients experienced lethargy, two patients experienced anorexia, seven patients experienced abdominal pain, one patient experienced diarrhea and four patients experienced constipation.Treatment for the events was not reported.At the time of this report, the patient outcomes were not reported.No additional information is available.

• 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 ; 2242702068
• MDR Report Key: 11862245
• MDR Text Key: 251904327
• Report Number: 1416980-2021-03082
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/21/2021
• 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
• Treatment: EXTRANEAL; TENCKHOFF CATHETER (NON- BAXTER)
• Patient Outcome(s): Required Intervention