MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IT MONITORING KIT W/SAFESET¿ RESERVOIR, 03 ML FLUSH DEVICE, 84" RED ST; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46106-23

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation.It is yet to be received.Possible lots: 4140117, mfr date 2019-07-01, exp date 2022-07-01; 4176540, mfr date 2019-07-01, exp date 2022-07-01; 4156588, mfr date 2019-07-01, exp date 2022-07-01.

Event Description

The customer reported the event occurred several minutes after the catheter was installed and during the first use of the tubing with blood collection.The nurse was attempting to collect blood from a transpac® it monitoring kit w/safeset¿ reservoir, 03 ml flush device, 84" red stripe pressure tubing and 2 needleless valves when the piston pin broke on the black plastic and blood came back and flooded the bed.The tubing was replaced, and therapy was resumed.There was patient involvement, but no adverse event nor human harm and no delay in critical therapy.

Manufacturer Narrative

One (1) used list # 011-46106-23, transpac® it monitoring kit w/safeset¿ reservoir, 03 ml flush device, 84" red stripe pressure tubing, and 2 needleless valves was received on december 12, 2019 for evaluation.The reported complaint of plunger detached from plunger tip was confirmed on the returned kit.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.The device history review for lot numbers 4140117, 4176540, 4156588, and 4176540 were reviewed and there were no relevant non-conformances found.

• Brand Name: TRANSPAC® IT MONITORING KIT W/SAFESET¿ RESERVOIR, 03 ML FLUSH DEVICE, 84" RED ST
• 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: 9371999
• MDR Text Key: 204997384
• Report Number: 9617594-2019-00407
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

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: 011-46106-23
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 500ML NACL, UNK MFR