MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ IRVINE INFUSOR; PUMP, INFUSION, PCA

Catalog Number 2C1067K

Device Problems Excess Flow or Over-Infusion (1311); Device Operates Differently Than Expected (2913)

Patient Problem Overdose (1988)

Event Date 03/27/2014

Event Type  Injury  

Manufacturer Narrative

Complaint no: (b)(4).Additional information: should additional relevant information become available, a follow-up will be submitted.

Manufacturer Narrative

(b)(4).As the sample was not returned and the lot number is unknown, a device analysis cannot be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a pediatric patient (pt), who was receiving morphine via a disposable pain management device, became ¿excessively sedated¿ soon after the pump was connected.Upon observing the issue, the device was disconnected from the pt.The device was reported to have been loaded with the ¿appropriate¿ concentration of morphine solution.The device was expected to deliver a bolus of 0.5 ml on every demand, not give any background infusion, and have a lockout period of 6 minutes.It was reported that the pump would continue to deliver fluids during the lockout period.There was patient involvement; however, it was unknown if there was patient injury or need for medical intervention.No additional information is available.

Manufacturer Narrative

(b)(4).The device is reported to be available but has not been received at this time.Should the device be received and evaluated or if additional relevant information becomes available, a supplemental report will be submitted.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, PCA
• 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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3841585
• MDR Text Key: 12069351
• Report Number: 1416980-2014-17484
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• PMA/PMN Number: K051253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2014

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: Physician
• Device Catalogue Number: 2C1067K
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2014
• Initial Date FDA Received: 05/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/31/2014; 09/22/2014
• 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
• Treatment: MORPHINE SOLUTION
• Patient Outcome(s): Other