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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PCA MODULE SETS; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION ALARIS PCA MODULE SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 10800173
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Requested patient demographics however not provided by the customer.
 
Event Description
The customer reported the pca set was punctured.The event occurred in the oncology unit.Although requested there are no additional details provided at this time.There was no indication of patient harm.A noted received with the product documented; "date adm (b)(6) 2019".
 
Event Description
The customer reported the pca set was "punctured".The event occurred in the oncology unit.Although requested there are no additional details provided at this time.There was no indication of patient harm.A noted received with the product documented; "date adm (b)(6) 2019".
 
Manufacturer Narrative
The customer¿s report the pca set was "punctured" was confirmed.Visual inspection of the set noted a cut in the suspect pca tubing approximately 2 inches below the antisiphon valve.There were no other anomalies observed.Functional testing confirmed leaking from the tubing approximately 2 inches below the antisiphon valve.Closer inspection of the leak under magnification observed a cut in the tubing that is approximately 0.151 in long.The root cause of the cut could not be identified.
 
Manufacturer Narrative
Correction on initial report d.4: disregard lot # 11611800.
 
Event Description
The customer reported the pca set was "punctured".The event occurred in the oncology unit.Although requested there are no additional details provided at this time.There was no indication of patient harm.A noted received with the product documented ; "date adm (b)(6) 2019".
 
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Brand Name
ALARIS PCA MODULE SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8382090
MDR Text Key137559993
Report Number9616066-2019-00553
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403234385
UDI-Public10885403234385
Combination Product (y/n)N
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup,Followup
Report Date 02/07/2019
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
Device Operator Health Professional
Device Model Number10800173
Device Catalogue Number10800173
Device Lot Number11611800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/01/2019
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received07/01/2019
07/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
2420-0007, THERAPY DATE UNK; 2420-0007, THERAPY DATE UNK
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