MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. PCA KIT ASV MICROBORE; INTRAVASCULAR ADMINISTRATION SET

Model Number	10800176
Medical Device Problem Codes	Leak/Splash (1354); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: (b)(4).
Event or Problem Description
It was reported that pca kit asv microbore leaked.The following information was provided by the initial reporter: material no: 10800176 batch no: unknown it was reported that there was two leaking incidences with the alaris pump tubing.Per customer email: we experienced (2) two separate leaking incidences with the alaris pump tubing.
Additional Manufacturer Narrative
H6.Investigation: no product or photo was returned by the customer.The root cause of this failure could not be identified without a failure investigation.A device history record review could not be performed on model 10800176 because an invalid lot number was provided by the customer.H3 other text : see h10.
Event or Problem Description
It was reported that pca kit asv microbore leaked.The following information was provided by the initial reporter: material no: 10800176, batch no: unknown.It was reported that there was two leaking incidences with the alaris pump tubing.Per customer email: we experienced (2) two separate leaking incidences with the alaris pump tubing.

• Brand Name: PCA KIT ASV MICROBORE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 10703561
• Report Number: 9616066-2020-20107
• Device Sequence Number: 3486365
• Product Code: FPA
• UDI-Device Identifier: 50885403234413
• UDI-Public: 50885403234413
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 10800176
• Device Catalogue Number: 10800176
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1