MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/SAFESET¿ RESERVOIR AND BLOOD SAMPLING PORT, 24" TU; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 426480406

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.The lot number of the device that was in use is unknown.The customer identified four possible lot numbers (plots).The possible lot numbers are 4112927 (expiry date 06/01/2022, mfr date 06/01/2019), 3947938 (expiry date 06/01/2022, mfr date 06/01/2019), 4046520 (expiry date 06/01/2022, mfr date 06/01/2019) and 3806275 (expiry date 06/01/2022, mfr date 06/01/2019).

Event Description

The event occurred on an unspecified date in (b)(6) 2019 and involved a transpac iv monitoring kit that when the plunger broke, a blood leak was noted out of the tip of the plunger.The device was replaced with a new one.There was patient involvement and no adverse event was reported.

Manufacturer Narrative

H10 - one used partial list# 426480406, transpac® iv monitoring kit w/safeset¿ reservoir and blood sampling port, 24" tubing, disposable transducer, 03 ml squeeze flush, macrodrip (patient mount), lot# unknown was received for evaluation on 8/7/2019.The reported complaint of leakage on the returned monitoring kit was not confirmed.The received set was pressure leak tested and no leaks were observed.The product was determined to meet product specifications.However, the plunger tip of the safeset reservoir was separated and unable to be pulled back.The probable cause was due to the clips not being fully inserted (engaged) into the mating component during the manufacturing process in ensenada.A lot history review could not be completed due to the unknown lot number.Additional information can be found in section g1.

• Brand Name: TRANSPAC® IV MONITORING KIT W/SAFESET¿ RESERVOIR AND BLOOD SAMPLING PORT, 24" TU
• 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: 8882759
• MDR Text Key: 198324731
• Report Number: 9617594-2019-00260
• Device Sequence Number: 1
• Product Code: DRS
• 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
• Report Date: 07/30/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 426480406
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1