MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BLD SET 200MF 20DP 1SPK; INTRAVASCULAR ADMINISTRATION SET

Model Number	10010985
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.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: unknown.(b)(4).
Event or Problem Description
It was reported that bld set 200mf 20dp 1spk had blood run through it.The following information was provided by the initial reporter: material #: 2426-0007, batch #: 20085891.It was reported that the tubing was backed up to the main iv and the nurse ran blood through the iv pump.Verbatim: this is the tubing that backed up to the main iv.Unable to sequester the tubing since it was discarded by the nurse.Per the night shift they were running the blood through the iv pump.
Event or Problem Description
It was reported that bld set 200mf 20dp 1spk had blood run through it.The following information was provided by the initial reporter: material #: 2426-0007; batch #: 20085891.It was reported that the tubing was backed up to the main iv and the nurse ran blood through the iv pump.Verbatim: this is the tubing that backed up to the main iv.Unable to sequester the tubing since it was discarded by the nurse.Per the night shift they were running the blood through the iv pump.
Additional Manufacturer Narrative
H.6.Investigation: 2 pictures were returned by the customer.It was reported that the tubing was backed up to the main iv and the nurse ran blood through the iv pump.Through observation of the pictures, the complaint can be verified.A device history record review could not be performed on model 10010985 because a lot number was not provided by the customer.The root cause of this failure was not identified due to no product being returned.H3 other text : see h.10.
Event or Problem Description
It was reported that bld set 200mf 20dp 1spk had blood run through it.The following information was provided by the initial reporter: material #: 2426-0007 batch #: 20085891.It was reported that the tubing was backed up to the main iv and the nurse ran blood through the iv pump.Verbatim: this is the tubing that backed up to the main iv.Unable to sequester the tubing since it was discarded by the nurse.Per the night shift they were running the blood through the iv pump.
Additional Manufacturer Narrative
The following fields were updated due to additional information: b.3.Date of event: (b)(6) 2020.

• Brand Name: BLD SET 200MF 20DP 1SPK
• 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: 10804959
• Report Number: 9616066-2020-20282
• Device Sequence Number: 2849621
• Product Code: FPA
• UDI-Device Identifier: 50885403233584
• UDI-Public: 50885403233584
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K882302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/31/2020

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 Model Number: 10010985
• Device Catalogue Number: 10010985
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 11/16/2020; 12/11/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 11/25/2020; 01/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1