MAUDE Adverse Event Report: ICU MEDICAL SAFESET TRANSPAC IV; BLOOD PRESSURE TRANSDUCER

Model Number 011-46103-25

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2017

Event Type  malfunction  

Manufacturer Narrative

Lot # 3359003 was reviewed.Lot of (b)(4) was manufactured and released with no exception documents cited.

Event Description

The facility reported that two 011-46103-25 safeset transpac iv were being used with vacuette/vacutainer to access the needleless valve to take a blood sample when the blue valve collapsed internally.There were no adverse patient consequences.The product was not returned, therefore no investigation could be conducted.

Manufacturer Narrative

Lot # 3359003 was reviewed.Lot of 600 units was manufactured and released with no exception documents cited.Visual inspection: received bag#1, one (1) used 011-46103-25, safeset¿ transpac® iv w/03 ml reservoir and single needleless valve, patient mount; lot# 3359003.One (1) unused vacuette container and one (1) used luer adaptor by greiner bio-one.Bag# 2, one (1) used 011-46103-25, safeset¿ transpac® iv w/03 ml reservoir and single needleless valve, patient mount; lot# 3359003 (drip chamber wasn't returned).Functional testing: the returned samples were visually examined.The luer activated valve was observed to be stuck down from having been folded over.Samples were not observed to have any discernible manufacturing defect.One of the samples were returned with a vacuette and a luer adaptor.The luer adapter was connected to the vacuette and the male luer appears to be too long for access of the marvelous valve.Final engineering analysis: the customer complaint of a stick down on the sampling port was confirmed.The returned samples were observed to have the marvelous valve depressed, and it was stuck in this condition.Although not always repeatable, previous engineering analysis of these valve components have shown recessed/leakage condition can potentially occur if the valve component is activated with a long luer or a luer with sharp edges at an angled entry.For optimal performance it is recommended to use connector devices that comply with iso 594-1 std.And techniques that employ a rotational motion while connecting and disconnecting the mating device to the valve.Icu medical will monitor and trend.

Event Description

The facility reported that two 011-46103-25 safeset transpac iv were being used with vacuette/vacutainer to access the needleless valve to take a blood sample when the blue valve collapsed internally.There were no adverse patient consequences.

• Brand Name: SAFESET TRANSPAC IV
• Type of Device: BLOOD PRESSURE TRANSDUCER
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84117
• Manufacturer Contact: bob gillispie ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641702
• MDR Report Key: 6916034
• MDR Text Key: 89850941
• Report Number: 2025816-2017-00215
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619037642
• UDI-Public: 840619037642
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Model Number: 011-46103-25
• Device Catalogue Number: 011-46103-25
• Device Lot Number: 3359003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1