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

Catalog Number 2C1063KP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6) the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient developed a rash and itching while receiving an infusion with a large volume (lv) 10 infusor.On an unreported date, the patient was hospitalized for an unreported indication.During the hospitalization, the patient was on intravenous (iv) flucloxacillin for several days for an unspecified infection with no adverse effects.To allow the patient to be discharged home, the patient was connected to a lv infusor containing baxter compounded flucloxacillin, 8 grams in 0.9% sodium chloride.The patient was discharged home on the same day.One day later, the patient experienced a rash which continued to worsen.The rash was described as itchy, red pinpoint on inner thighs, inner arms, wrists, groin area and lower trunk.According to the patient, this is the first time that skin rash was experienced.Initially the patient tolerated the rash by taking unspecified antihistamine tablets.By day three, the rash was noted to be tender and showed signs of edema so the patient was re-admitted to the hospital.A peripherally inserted central catheter (picc) line was removed (described as infiltrated) and the patient was switched to oral antibiotics.On an unreported date, after disconnection from the infusor, the rash was resolved.Recently during hospitalization, the patient received 8 days of iv flucloxacillin without the rash developing again (mode of infusion was not reported).It was reported that while the patient was connected to the infusor, the patient¿s infection showed definite signs of improvement (unspecified).At the time of this report, the patient remained disconnected from the infusor and the patient was not recovered from the unspecified infection.No additional information is available.

Manufacturer Narrative

It was reported during follow up that the patient was receiving treatment with flucloxacillin for cellulitis (previously reported as an unspecified infection).It was reported that other than treating the rash with unspecified antihistamines, there was no further treatment required for the rash.On an unreported date, additional unspecified antibiotics were prescribed to the patient (indication, doses, frequencies, routes and durations were not reported).At the time of this report, the patient was still being treated for cellulitis, however, it is now thought that there may have been another underlying condition.No further detail was provided regarding the patient¿s outcome from the event.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 avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7397027
• MDR Text Key: 104365700
• Report Number: 1416980-2018-01860
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081366
• UDI-Public: (01)00085412081366
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K071222
• 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,Followup
• Report Date: 05/08/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: 2C1063KP
• Device Lot Number: 17F062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• 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: 0.9% SODIUM CHLORIDE; FLUCLOXACILLIN (UNSPECIFIED); PICC LINE (UNSPECIFIED BRAND)
• Patient Outcome(s): Hospitalization; Required Intervention