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

Catalog Number 2C1063KP

Device Problem Filling Problem (1233)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The events occurred on an unspecified dates in 2020, reported as used over (b)(6) 2020 and (b)(6) 2020.Potential lot numbers reported were 19k049 and 19j047.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported fifteen (15) large volume infusors under infused.The caregiver (cg) reported the patient did not receive the prescribed dose of antibiotic treatments ¿over a number of 24-hour periods¿ which resulted in recurrent osteomyelitis.The cg reported ¿about 15¿ infusors received at home were "overfilled" and there was residual volume of medication in the infusor at the end of the infusion ¿approximately 20 ml or 19g¿.The patient was hospitalized for recurrent left distal tibial osteomyelitis event.Treatment for the event was not reported.The patient was discharged nine days after hospital admission.At the time of this report, the patient outcome was reported as ¿unresolved outcome¿.No additional information is available.

Manufacturer Narrative

The device was manufactured from (b)(6) 2019 - (b)(6), 2019.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.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 CORPORATION; deerfield IL
• MDR Report Key: 10398424
• MDR Text Key: 202611253
• Report Number: 1416980-2020-04915
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

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 Catalogue Number: 2C1063KP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8G FLUCLOXACILLIN IN 240ML SODIUM CHLORIDE; 8G FLUCLOXACILLIN IN 240ML SODIUM CHLORIDE
• Patient Outcome(s): Hospitalization
• Patient Weight: 80