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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ1000-07
Device Problem Partial Blockage (1065)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/12/2018
Event Type  malfunction  
Manufacturer Narrative
Cont¿d concomitant medical product(s): 10 ml bd syringe refr306547, lot number 8107773, exp 2021-04-03, 0. 9% sodium chloride; picc. The customer¿s report of an occlusion was not confirmed or replicated. Visual inspection showed no anomalies on the connector. Functional testing resulted in no occlusions, leaking, or other issues. The root cause of the reported occlusion could not be determined.
 
Event Description
The customer reported that on the cvicu, a tpn infusion alarmed twice for an "occlusion, patient side". The infusion was restarted. The third time the infusion alarmed, the infusion couldn't be restarted. The product was found to be occluded, which impeded the flow of milrinone, "epi", "dex", pge, tpn, and lipids. The product was changed and blood return was checked. The line continued to be somewhat "sluggish" due to positional reasons, but its usability was restored. There was no patient harm.
 
Event Description
The customer reported that on the cvicu, a tpn infusion alarmed twice for an "occlusion, patient side". The infusion was restarted. The third time the infusion alarmed, the infusion couldn't be restarted. The product was found to be occluded, which impeded the flow of milrinone, "epi", "dex", pge, tpn, and lipids. The product was changed and blood return was checked. The line continued to be somewhat "sluggish" due to positional reasons, but its usability was restored. There was no patient harm.
 
Manufacturer Narrative
After review it was determined that this complaint is not mdr reportable.
 
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Brand NameMAXZERO NEEDLELESS CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key7970513
MDR Text Key124977374
Report Number9616066-2018-01896
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K132413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMZ1000-07
Device Catalogue NumberMZ1000-07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2018
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/16/2018 Patient Sequence Number: 1
Treatment
(6)8100,(6)2432-0007,(2)8015,TD (B)(6) 2018
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