MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number 11448964

Device Problem Material Separation (1562)

Patient Problems Chemical Exposure (2570); No Code Available (3191)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

No product will be returned per customer because the product was discarded.Admitting diagnosis: outpatient treatment for breast cancer although requested, information on race, ethnicity, and relevant history were not provided.

Event Description

It was reported from the durham regional cancer centre that when the nurse went to hang the cyclophosphamide chemotherapy bag on the intravenous (iv) pole, the secondary tubing set separated at the drip chamber.Although the nurse was wearing personal protective equipment (ppe), a small amount of chemotherapy medication splashed on the nurse's face and required medical assessment.Also, there was exposure of the cytotoxic chemotherapy medication on the patient's skin that did not require medical intervention.

Manufacturer Narrative

No product will be returned per customer.The customer complaint of tubing set separated at the drip chamber and leaked was confirmed.Photo provided by the customer shows that the tubing was completely separated from the drip chamber inlet port.Fluid was observed to be leaking from the separation.The root cause of this failure was not identified as no product was returned.Device history record for model 11448964 lot 20025679 shows that the set was manufactured on 13 february 2020 with a total of (b)(4) units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.

Event Description

It was reported from the durham regional cancer centre that when the nurse went to hang the cyclophosphamide chemotherapy bag on the intravenous (iv) pole, the secondary tubing set separated at the drip chamber.Although the nurse was wearing personal protective equipment (ppe), a small amount of chemotherapy medication splashed on the nurse's face and required medical assessment.Also, there was exposure of the cytotoxic chemotherapy medication on the patient's skin that did not require medical intervention.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10176948
• MDR Text Key: 195902250
• Report Number: 9616066-2020-01906
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403234743
• UDI-Public: 10885403234743
• Combination Product (y/n): N
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

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: Health Professional
• Device Expiration Date: 02/13/2023
• Device Model Number: 11448964
• Device Catalogue Number: 11448964
• Device Lot Number: 20025679
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 112