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

Catalog Number 2C1009KP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Itching Sensation (1943); Rash (2033); Vomiting (2144); Confusion/ Disorientation (2553)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

Postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a baxter infusor infused into the patient faster than expected.The patient was infused with 100ml of lidocaine in approximately 12 hours; however, the customer expected fill duration was 20 hours.The cause of the event was determined to be a use error as the patient used a infusor with a designed nominal fill volume of 240ml, approximate residual volume of 3ml, nominal flow rate of 5 ml/hr set to deliver in 48 hours, and the maximum fill volume of the device is 300ml.The infusor was only filled with 100ml which is 41.6% below the required nominal fill volume indication on the instruction for use.The patient began experiencing side effects on the same day, approximately four hours after starting therapy, however the patient did not clamp the infusor immediately.The symptoms included projectile vomiting, itching, rash all the way up to the patient¿s waist, with some on the stomach and chest and the back of hands, exacerbated hyperalgesia, increased scent, difficulty speaking, confusion and felt disoriented.Three hours later, the patient also reported feeling their "liver was bubbling".Approximately twelve hours after starting therapy, the patient clamped the line to the infusor to prevent further infusion.One hour after clamping the infusor, the patient took benadryl.The next day, the patient called the clinic to report events that occurred the day before and reported the infusor looked almost empty.The patient was advised to ensure that the infusor was clamped and to detach the catheter; however, the patient preferred to leave everything intact.Medical intervention was unknown.At the time of this report the patient had recovered from the event.No additional information is available.

Manufacturer Narrative

The cause of the event was determined to be a use error as the patient used an infusor with a designed nominal fill volume of 240ml, approximate residual volume of 3ml, nominal flow rate of 5 ml/hr set to deliver in 48 hours, and the maximum fill volume of the device is 300ml.Under filling this device below the nominal fill volume set in the directions for use will cause over infusion to occur.The infusor was only filled with 100ml which is 41.6% below the required nominal fill volume indication in the instruction for use.A review of the label for the product family will be conducted.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 - IRVINE; irvine CA
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong ave.; building 3; irvine CA 92614 ; CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6186213
• MDR Text Key: 62743939
• Report Number: 1416980-2016-18526
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

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: Lay User/Patient
• Device Catalogue Number: 2C1009KP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other