MAUDE Adverse Event Report: B BRAUN ON-Q; ELASTOMERIC PAIN PUMP

Lot Number 17BO3GE561

Device Problems Excess Flow or Over-Infusion (1311); Application Program Problem: Medication Error (3198)

Patient Problems Hypoglycemia (1912); Overdose (1988); Vomiting (2144); Confusion/ Disorientation (2553)

Event Date 02/20/2018

Event Type  Injury  

Event Description

The patient was incompetent so history was obtained from family members in the hospital on the afternoon of (b)(6).On (b)(6), the patient was seen in the oncologist's office for his colorectal cancer which was diagnosed in (b)(6) of 2017.The patient received a dose of oxaliplatin while in the clinic on (b)(6) and was subsequently connected to a b braun on-q infusion ball 270 ml filled with fluorouracil - lot 17bo3ge561.This device was filled with fluorouracil (5-fu) 4850mg/0.9 percent nacl 230ml to be infused over 46 hours via elastomeric.The rate was set at be 5 ml/hr; dose 2400 mg/m2 bsa 2.2 m2.The patient's wife describes the following sequence of events: the patient and wife visited oncologist office at 1600 on (b)(6) with a normal state of health.They left at this time with the device attached to his port and infusing.Provided booklet on how to care for the pump.Was instructed the pump would run x 46 hours.At 0100 on (b)(6), the patient awoke from sleeping and vomited and returned to bed.At 0300, the patient was mentally altered.The wife explains that he, "began taking off his clothes and saying irrational things." at this time, she notes he was no longer mentally stable and unsure of his unusual change in mental status.At an unknown time in the early morning of (b)(6), the patient's wife took his blood sugar which resulted in a reading in the 30's.She gave her husband, the patient, angel flood cake, coke, and juice.His blood sugar subsequently increased to 300 on next check.She notes he has never had a blood sugar reading that low before and his mental status did not change after hypoglycemia was corrected.The patient arrived at the ed at 1704 on (b)(6).Was admitted to the ccu at 2339 and was discharged to (b)(6) at 2205 on (b)(6).At an unknown time during hospitalization, it was first noted that the device was completely empty.When questioned, the patient's wife had not checked the device prior to being admitted to the hospital.The device was being housed in a non-transparent fanny pack-like carrying case that was sealed with a zipper.The patient was ordered vistogard 10 grams every 6 hours after contacting the oncologist and received confirmation this medication was appropriate in this scenario.This medication was transported via air to our facility overnight.Received the first dose at 1113 on (b)(6).Diagnosis or reason for use: chemotherapy.

• Brand Name: ON-Q
• Type of Device: ELASTOMERIC PAIN PUMP
• Manufacturer (Section D): B BRAUN
• MDR Report Key: 7334192
• MDR Text Key: 102440929
• Report Number: MW5075817
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/09/2018

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: Lay User/Patient
• Device Lot Number: 17BO3GE561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 58 YR
• Patient Weight: 71