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

Catalog Number 2C1811K

Device Problems Filling Problem (1233); Improper or Incorrect Procedure or Method (2017)

Patient Problems Low Blood Pressure/ Hypotension (1914); Neurological Deficit/Dysfunction (1982); Dizziness (2194)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

An infusor flowed faster than expected and as a result, a patient experienced dizziness, sudden hypotension, and long-term motor blockage.The infusor was filled with a combined volume 275 ml (levobupivacaine 0,125% and nacl (sodium chloride)).The indication was analgesia after vascular bypass surgery.The infusion was delivered by an epidural catheter and the patient was lying with the infusor at bed height.It was reported that the infusor flowed at a rate estimated to be more than 15 ml/hour, which was three times the expected flow rate of 5 ml/hour.Twenty to thirty minutes after the infusion began, the patient felt dizzy.As a result, the infusor was removed and the infusion was discontinued.At that time, the patient suffered sudden hypotension and long-term motor blockage (unable to move legs).Crystalloids (phenylephrine hydrochloride) were administered as treatment (dose, frequency, and route not reported) and the hypotension reversed after one half hour.A hemodynamic vigilance protocol (not further specified) was set up for the motor blockage.This protocol required the patient to remain under observation in the unit for 24 hours, which caused a delay in the discharge of the patient from the reanimation (rea) unit of the hospital.Subsequently, the patient remained in the unit eight additional hours for the blockage, which lasted for approximately 6-7 hours.Thirty-six hours after the initiation of infusion, the patient was discharged from the hospital.No further detail was provided regarding the outcome from the event.No additional information is available.

Manufacturer Narrative

The actual device and one companion sample were received on 03/27/2017.And the second companion sample was received on 03/28/2017.The actual device and two companion samples were received for evaluation.Visual inspection of the companion samples did not identify any abnormalities that could have contributed to the reported condition.Visual inspection of the actual device revealed the line was observed to not be clamped and the pcm shipping tab was not removed.The flow rate on the multirate control module of the actual unit was observed to have been set at 5ml.During flow rate testing of the actual device, the flow rate was set at 5ml on the multirate control module and the line was not clamped and the pcm shipping tab was not removed, the flow rate was found to be 15ml per hour (¿triple¿ the set flow rate of 5ml per hour).When the line was clamped and the pcm shipping tab was removed, the flow rate was found to be 5ml per hour.A functional flow rate test was performed on the two companion samples, and both were found to be within the product specification range.Therefore, the reported condition was not verified.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.

Manufacturer Narrative

During visual inspection of the actual unit, the line was observed to not be clamped and the pcm shipping tab was not removed.The flow rate on the multirate control module was observed to have been set at 5ml.According to the product direction insert, failure to remove the shipping tab will cause continuous infusion and patient may receive higher than intended basal dose of pain medication.A functional flow rate test was performed on both the actual and companion units using the condition reported in the complaint event description.The flow rate was set at 5ml on the multirate control module and the line was not clamped and the pcm shipping tab was not removed, the flow rate was found to be 15ml per hour (¿triple¿ the set flow rate of 5ml per hour) indicating a user error.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; irvine CA
• 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: 6437084
• MDR Text Key: 70968466
• Report Number: 1416980-2017-02698
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K051253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C1811K
• Device Lot Number: 16C062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2016
• 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
• Treatment: EPIDURAL CATHETER ; LEVOBUPIVACAINE 0,125% AND NACL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR