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

Catalog Number J2C1009

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device was manufactured from may 20, 2020 ¿ may 21, 2020.One actual device was received for evaluation.The unit was returned containing approximately 124ml of fluid in the bladder.A visual inspection was performed on the unit via the naked eye which showed no evidence of fluid coming out at the distal end of the flow restrictor.Inspection on the flow restrictor revealed the cause of the flow problem was due to air bubbles blocking the fluid path inside the lumen of the capillary glass.The capillary glass is located inside the flow restrictor housing.No additional observations were found.The reported condition was verified.The cause was not determined, however, the potential cause of the air bubbles may be due improper filling technique during product use (filling step).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.

Event Description

It was reported that the delivery of a large volume infusor stopped during a patient infusion at the hospital.There was no report of patient injury or medical intervention associated with this event.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 60073 ; 2242702068
• MDR Report Key: 11287103
• MDR Text Key: 231789710
• Report Number: 1416980-2021-00429
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: J2C1009
• Device Lot Number: 20E052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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