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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number L5C4531
Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem No Patient Involvement (2645)
Event Date 10/24/2017
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation and an evaluation is complete.A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot.A visual inspection was performed with the naked eye.Functional testing was performed which included leak testing, clear passage testing, and clamp function testing.Cut tubing on the supply line, fill line, patient line, drain line, and several cuts to the cassette sheeting were identified during visual inspection.The unit leaked through the cuts on the tubing lines and cassette sheeting.The cause of event was determined to be flow wrap damage during manufacturing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
During evaluation of a returned homechoice automated pd set with cassette, a baxter technician determined that the device leaked through the cuts on the tubing lines and cassette sheeting.There was no patient involvement.No additional information is available.
 
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Brand Name
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE - MOUNTAIN HOME
mountain home AR
Manufacturer (Section G)
BAXTER HEALTHCARE - MOUNTAIN HOME
1900 n highway 201
mountain home AR 72653
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6990002
MDR Text Key90888134
Report Number1416980-2017-08667
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102936
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/31/2017
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
Device Operator Other
Device Catalogue NumberL5C4531
Device Lot NumberH17F24032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2017
Initial Date Manufacturer Received 10/25/2017
Initial Date FDA Received10/31/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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