MAUDE Adverse Event Report: ICU MEDICAL, INC. 42 CM PUR EXT. SET

Model Number 011-H2504

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Complaint received regarding one 011-h2504, 42cm pur ext.Set with bag spike w/integrated clave, bcv and cap with filter, lot# 3260908, (mfd.05/2016).Report states; "sudden leakage occurred on manipulator nurse before patient treatment was started." nurse had burn on hand from leak of taxol.Unprotected chemo leakage.The leak was cleaned per standard hospital protocol.No patient involvement.

Manufacturer Narrative

(b)(4).Visual analysis of returned product: one used 011-h2504, 42cm pur ext.Set with bag spike w/integrated clave, bcv and cap with filter, reported lot# 3260908.One used icu bag spike with two clave ports and a dry spike adapter.One used bag spike admin set with injection port.One used bag spike admin set with 0.2micron filter.One used macopharma 50ml saline iv bag.One used macopharma 100ml saline iv bag.One used macopharma 250ml saline iv bag.The 011-h2504 was spiked into the 250ml saline bag and connected to one of the claves of the dry spike adapter.The bag spike with filter was spiked into the dry spike adapter.The second admin set was spiked into the 50ml saline bag and the distal end was connected to the stopcock of the first admin set.The setup was flushed and no leaks were observed.All three bag spikes were not fully inserted into the iv bags.Functional testing: the returned set up as received was leak tested by first filling the returned bags that were attached to the 011- h2504 device and the unknown icu bag spike with two clave ports and a dry spike adapter with water.The set up (both bags) were placed on an iv pole set at 36" head height.The lines were primed with water from the bags and then the outlet port was capped off for 30 seconds.No leakage or separation was observed.Note: the bag spikes on both sets were not securely attached all the way into the bag ports.The bag spikes were pull tested from the bag ports as received and then pull tested after the bag spikes were securely attached all the way on over the rise of the bag ports.The 011- h2504 spike pull tested from the bag port as received: 3.6 lbs.The 011- h2504 spike pull tested from the bag port after securely attached: 7.8 lbs.The unknown bag spike with two clave ports pull tested from the bag port as received: 4.0 lbs.The unknown bag spike with two clave ports pull tested from the bag port after securely attached: 8.4 lbs.Final analysis summary: the reported product problem for leakage could not replicated/confirmed.Although leakage was not replicated with the returned set, it was noticed that the bag spikes were not securely attached to the bag ports and this could cause a leak or separation.The bag port needs to be securely attached all the way onto the bag spike over the rise and flush with the base of the bag spike.

Event Description

Complaint received regarding one 011-h2504, 42 cm pur ext.Set with bag spike w/integrated clave, bcv and cap with filter, lot# 3260908, (mfd.05/2016).Report states; "sudden leakage occurred on manipulator nurse before patient treatment was started." nurse had burn on hand from leak of taxol.Unprotected chemo leakage.The leak was cleaned per standard hospital protocol and the nurse was given first aid.No patient involvement or adverse consequences reported.

• Brand Name: 42 CM PUR EXT. SET
• Type of Device: 42 CM PUR EXT. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: bob gillispie ; 4455 atherton dr.; salt lake city, UT 84123 ; 8012641702
• MDR Report Key: 5910694
• MDR Text Key: 53381987
• Report Number: 2025816-2016-00108
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K964435
• 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: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/01/2021
• Device Model Number: 011-H2504
• Device Catalogue Number: 011-H2504
• Device Lot Number: 3260908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1