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

Model Number	ME1247
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Patient is an adult.
Event or Problem Description
It was reported from (b)(6) patient centered care (pcc) 8 south oncology unit that the y-site junction of the bifuse extension set had leaked cyclophosphamide.It was noted that the treatment was delayed by 20 minutes to allow for reporting, documentation, and replacement of tubing set.There were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
Corrections: updated b3 ,b5, and additional information added to: d11.
Event or Problem Description
It was reported that that a small amount of leakage was seen at the engagement of bifuse extension set during an infusion of chemotherapy cyclophosphamide through secondary set.The medication was being administered using a non-bd infusion pump.It was noted that the rn had to put absorbent pads underneath the extension set due to the clinician¿s previous experience of leaks regarding the same tubing.The certified nurse educator (cne) attempted to replicate the leak, but unable to do so and instead, recommended that in future, to use the sets with caution and to have an absorbent pad underneath, in case of leaks.The treatment was delayed for about twenty minutes to allow for event reporting to cne, documentation, and replacement of the tubing.There was no patient impact.The event occurred at the oncology unit.
Event or Problem Description
It was reported that that a small amount of leakage was seen at the engagement of bifuse extension set during an infusion of chemotherapy cyclophosphamide through secondary set.The medication was being administered using a non-bd infusion pump.It was noted that the rn had to put absorbent pads underneath the extension set due to the clinician¿s previous experience of leaks regarding the same tubing.The certified nurse educator (cne) attempted to replicate the leak, but unable to do so and instead, recommended that in future, to use the sets with caution and to have an absorbent pad underneath, in case of leaks.The treatment was delayed for about twenty minutes to allow for event reporting to cne, documentation, and replacement of the tubing.There was no patient impact.The event occurred at the oncology unit.
Additional Manufacturer Narrative
The customer complaint of tubing set leaked at y-site was confirmed.A photo provided by the customer shows fluid leaking from the tubing to the inlet port of the 3-way connector.Device history record for model me1247 lot 18085986 shows that the set was manufactured on 10 august 2018 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.The root cause of this failure was not identified as no product was returned.
Additional Manufacturer Narrative
Correction on follow-up(1): g.4 (05/13/2020).
Event or Problem Description
It was reported that that a small amount of leakage was seen at the engagement of bifuse extension set during an infusion of chemotherapy cyclophosphamide through secondary set.The medication was being administered using a non-bd infusion pump.It was noted that the rn had to put absorbent pads underneath the extension set due to the clinician¿s previous experience of leaks regarding the same tubing.The certified nurse educator (cne) attempted to replicate the leak, but unable to do so and instead, recommended that in future, to use the sets with caution and to have an absorbent pad underneath, in case of leaks.The treatment was delayed for about twenty minutes to allow for event reporting to cne, documentation, and replacement of the tubing.There was no patient impact.The event occurred at the oncology unit.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10120750
• Report Number: 9616066-2020-01859
• Device Sequence Number: 1762042
• Product Code: FPA
• UDI-Device Identifier: 10885403274305
• UDI-Public: 10885403274305
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/13/2020

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2023
• Device Model Number: ME1247
• Device Catalogue Number: ME1247
• Device Lot Number: 18085986
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 06/11/2020; 07/13/2020; 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Concomitant Medical Products and Therapy/Usage Dates: SIGMA 8 PUMP, PRI TUBING, TD (B)(6) 2020