MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	42800-28
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.
Event or Problem Description
The event occurred in the intensive care unit (icu) and involved a transpac¿ it monitoring kit, 84" safeset reservoir, 2 blood sampling port, 3ml flush device, macrodrip where the blue ¿fast flush¿ device has broken off the plunger located on the pull back mechanism.A back flow of blood was noted through the pull back, out the hole on top of it and puddled onto the patient's floor.It was reported there was no medication involved.This report reflects the second incident of two.
Additional Manufacturer Narrative
H10 - no product sample(s) were returned and no photographs or videos were provided for investigation.Therefore, a comprehensive failure investigation was unable to be performed.However, a parallel investigation was conducted on similar complaints which indicate the plunger was detached from plunger tip with the plunger tip unable to be pulled back within the safeset reservoir.The detached plunger from plunger tip would lead to unable to draw blood.The probable cause of the detached plunger tip from the plunger is due to the clips not being fully inserted or engaged into the mating component during the manufacturing process in ensenada.A device history review (dhr) for lot# 4140090 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint additional information can be found in section h6.
Additional Manufacturer Narrative
Additional contact information provided on the ufmw: contact person: (b)(6).
Event or Problem Description
A user facility mandatory medwatch, #: 302260000-2020-8003, was received on may 19, 2020.

• Brand Name: TRANSPAC IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 9898148
• Report Number: 9617594-2020-00098
• Device Sequence Number: 19524119
• Product Code: DRS
• UDI-Device Identifier: 00887709098008
• UDI-Public: (01)00887709098008(17)220601(10)4140090
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2020

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 Expiration Date: 06/01/2022
• Device Catalogue Number: 42800-28
• Device Lot Number: 4140090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/30/2020; 05/19/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 05/05/2020; 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1