MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/SPINNING SPIROS, C-CLIP, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH3581
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If additional information becomes available a supplemental report will be submitted.The lot history was reviewed and there were no relevant non-conformance's found that would have contributed to the reported complaint.
Event or Problem Description
The event involved an oncology kit w/spinning spiros®, c-clip, red cap that had a spill of a cytarabine, a chemo drug.It was reported that the spiros kept falling off after it was attached with a c-clamp to the bd alaris bag tubing.The spiros disconnected at the point of attachment to the patient 15 hours into a 24hour continuous infusions of cytarabine.The chemo spill came in contact with the patient and the healthcare provider.It was also cleaned per protocol, the bag was discarded, and a new order was replaced.There was patient involvement but no adverse event, no blood loss or bleed back.
Additional Manufacturer Narrative
Correction found in b5: describe event or problem and e4: initial report sent to fda.
Event or Problem Description
A user facility mandatory medwatch was received that stated, "cytarabine primed with alaris tubing and with icu spinning spiros device at the end came disconnected at the point of the spiros, 15 hours into a 24 hour continuous infusion of cytarabine".

• Brand Name: ONCOLOGY KIT W/SPINNING SPIROS, C-CLIP, RED CAP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 11731881
• Report Number: 9617594-2021-00138
• Device Sequence Number: 17085126
• Product Code: FPA
• UDI-Device Identifier: 00887709079243
• UDI-Public: (01)00887709079243(17)250901(10)5000420
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

1 Device was Involved in the Event

1 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: 09/01/2025
• Device Catalogue Number: CH3581
• Device Lot Number: 5000420
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 05/13/2021
• 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: BD ALARIS BAG TUBING, REF (B)(4), LOT(10)20116052.; CYTARABINE DRUG, MFR UNK.; BD ALARIS BAG TUBING, REF (B)(4), LOT(10)20116052; CYTARABINE DRUG, MFR UNK