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

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 03/06/2020

Event Type  malfunction  

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 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.

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.

Manufacturer Narrative

Additional contact information provided on the ufmw: contact person: (b)(6).

Event 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
• Type of Device: 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
• MDR Text Key: 219528888
• Report Number: 9617594-2020-00098
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00887709098008
• UDI-Public: (01)00887709098008(17)220601(10)4140090
• Combination Product (y/n): N
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: 42800-28
• Device Lot Number: 4140090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1