MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM SUK; CENTRAL VENOUS START UP KIT

Model Number	8700-0666
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The zoll suk catheter was returned to zoll for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
As reported during patient use, 28 to 30 hours after the catheter was placed into the patient body, the console exhibited an air trap alarm, blood was noted on the saline bag and a leak was suspected.The suk and catheter was removed however were not replaced.No patient harm or consequence was reported.Reference mfr # 3010617000-2017-00821 for catheter.
Additional Manufacturer Narrative
During visual inspection, blood was noted inside the returned suk confirming the customer reported complaint.No additional testing was performed with the suk because the leak was found with the returned quattro catheter.Reference mfr 3010617000-2017-00821 for catheter.

• Brand Name: ZOLL IVTM SUK
• Common Device Name: CENTRAL VENOUS START UP KIT
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 6904823
• Report Number: 3010617000-2017-00826
• Device Sequence Number: 483128
• Product Code: NCX
• UDI-Device Identifier: 00849111075336
• UDI-Public: 0849111075336
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K014241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2017

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: No Information
• Device Model Number: 8700-0666
• Device Catalogue Number: 8700-0666
• Device Lot Number: 69780
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 55