MAUDE Adverse Event Report: CAREFUSION ALARIS INFUSION SET; SET, INFUSION, INTRAVASCULAR

Model Number	10015862
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
The customer reported that the tubing spike which was in a 1000ml bag of etoposide, doxorubicin, and vincristine (vesicants) had dislodged from the bag and spilled on the nurse.The short primary tubing was connected very close to the pump.The nurse reported that she felt as if her skin was burning, similar to a sunburn, as a result of the chemo spilling on her.The area did not blister and she did not see a physician.The customer stated that no medical intervention was required.
Event or Problem Description
The customer reported that the tubing spike which was in a 1000ml bag of etoposide, doxorubicin, and vincristine (vesicants) had dislodged from the bag and spilled on the nurse.The short primary tubing was connected very close to the pump.The nurse reported that she felt as if her skin was burning, similar to a sunburn, as a result of the chemo spilling on her.The area did not blister and she did not see a physician.The customer stated that no medical intervention was required.Received a copy of the customer's maude report from the fda which states, "during the infusion of a 1000 ml bag of (etoposide, doxorubicin, vincristine vesicants) the spike came out of the bag and spilled all over the nurse.Background, the bag was spiked using a short primary tubing and connected to an alaris pump.Pt ambulated to the bathroom, an rn waited for the pt.Rn noticed that there was a bubble in the iv tubing and lightly flicked the tubing to get rid of the bubble; instead the iv tubing detached from the bag and as a result there was a chemo spill.Result: the nurse felt as if her skin was burning, similar to a sunburn.She did not see a physician, it did not blister.Pt was not harmed or spilled on.Spilled chemo bag was disposed appropriately and new chemo bag was given / hung.Product info: the model / ref number of the tubing is (b)(4) (carefusion).The model / ref number of the normal saline bag is e8000 (b)(4) (bbraun) assessment.Due to the stiffness of the port of the bag and the unsecured nature of the connection between the port of the bag and the iv tubing our institution will switch products to prevent other chemo spills.".
Event or Problem Description
It was reported that the tubing spike in a 1000ml bag of etoposide, doxorubicin, and vincristine (vesicants) dislodged from the bag and spilled onto the nurse.The tubing was a short primary chemo set, and was connected close to the pump.The nurse reported that she felt as if her skin was burning similar to a sunburn as a result of the chemo spill.The affected area did not blister and she did not see a physician.The customer stated that no medical intervention was required, and that the patient was not harmed.Received a copy of the customer's maude report from the fda which states, "during the infusion of a 1000 ml bag of (etoposide, doxorubicin, vincristine vesicants) the spike came out of the bag and spilled all over the nurse.Background, the bag was spiked using a short primary tubing and connected to an alaris pump.Pt ambulated to the bathroom, an rn waited for the pt.Rn noticed that there was a bubble in the iv tubing and lightly flicked the tubing to get rid of the bubble; instead the iv tubing detached from the bag and as a result there was a chemo spill.Result: the nurse felt as if her skin was burning, similar to a sunburn.She did not see a physician, it did not blister.Pt was not harmed or spilled on.Spilled chemo bag was disposed appropriately and new chemo bag was given / hung.Product info: the model / ref number of the tubing is (b)(4) (carefusion).The model / ref number of the normal saline bag is e8000 (b)(4) (bbraun) assessment.Due to the stiffness of the port of the bag and the unsecured nature of the connection between the port of the bag and the iv tubing our institution will switch products to prevent other chemo spills." customer advocacy received a copy of the customer's medwatch report from the fda which states, "safety concern; chemo spill:summary:during the infusion of a 1000 ml bag of etoposide, oxorubicin, vincristine (vesicants),the spike came out of the bag and spilled all over the nurse.Background: the bag was spiked using a short primary tubing and connected to an alaris pump.Patient ambulated to the bathroom, as rn waited for the patient, rn noticed that there was a bubble in the iv tubing and lightly flicked the tubing to get rid of the bubble: instead the iv tubing detached from the bag and as a result there was a chemo spill.Result:the nurse felt as if her skin was burning, similar to a sunburn.She did not see a physician, it did not blister.Patient was not harmed or spilled on.Spilled chemo bag was disposed appropriately and new chemo bag was given/hung.Product information: the model/ref number of the tubing is 10015862 (carefusion).The model/ref number of the normal saline bag is e8000, ndc (b)(4) (bbraun).Assessment: due to the stiffness of the port of the bag and the unsecured nature of the connection between the port of the iv tubing, our institution will switch products to prevent other chemo spills.Relevant materials provided: image.(b)(6).(b)(4).".
Additional Manufacturer Narrative
Additional medwatch information provided.

• Brand Name: ALARIS INFUSION SET
• Common Device Name: SET, INFUSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8199541
• Report Number: 9616066-2018-02591
• Device Sequence Number: 1616921
• Product Code: FPA
• UDI-Device Identifier: 10885403221866
• UDI-Public: 10885403221866
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2018

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
• Operator of Device: Health Professional
• Device Model Number: 10015862
• Device Catalogue Number: 10015862
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 02/01/2019; 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8100, 8015
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Weight: 70