MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM ICY CATHETER; CENTRAL VENOUS CATHETER

Model Number	IC-3893
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The icy catheter (lot# 150505) in complaint was returned to zoll on 09 february 2021 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
Approximately 9 hours after the initiation of the ivtm therapy, the nurse observed that the saline bag decreased and bed sheet was wet.Following this, the thermogard xp ivtm system (sn unknown) and start-up kit was replaced.After 5 hours and 32 minutes, again saline leak was observed.The user replaced the icy catheter and suk.It was observed that there was a crack on the inflow leur of the icy catheter (lot# 150505).No consequences or impact to patient.Please see the following related mfr reoprt: mfr # 3010617000-2021-00198 for the thermogard xp ivtm system.
Additional Manufacturer Narrative
Correction in h4: updated the manufacturing date.The reported complaint about the icy catheter (lot # 151375) leak and cracked in-luer was confirmed during visual inspection and functional testing.The probable root cause for the cracked luer could be due to a latent material defect or due to over torqueing of the luer.Visual inspection of the returned catheter was performed and found the "in" luer lock connection was cracked.Noticed blood residues in the distal luered tubings.Functional testing of the returned catheter was performed.All infusion ports and extension tubes were flushed without resistance.The returned catheter was connected to the pressurized inflation device and upon pressurizing the catheter, a water/emission/leak was observed at the "in" luer lock connection; thus confirming the reported complaint.It is unlikely that the defective catheter was shipped.During manufacturing, all catheters are 100% inspected for leaks by subjecting them to pressure testing.Only units that passed are moved to the next process.Historical complaints were reviewed for information related to the reported complaint and there was no previous history of complaint reported for the icy catheters with lot # 151375.

• Brand Name: ZOLL IVTM ICY CATHETER
• Common Device Name: CENTRAL VENOUS CATHETER
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 11355218
• Report Number: 3010617000-2021-00192
• Device Sequence Number: 11404046
• Product Code: NCX
• UDI-Device Identifier: 00849111075527
• UDI-Public: 00849111075527
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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
• Operator of Device: Health Professional
• Device Model Number: IC-3893
• Device Catalogue Number: 8700-0782-03
• Device Lot Number: 150505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1