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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REYNOSA PLANT CUSTOM COMBI SET
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REYNOSA PLANT CUSTOM COMBI SET Back to Search Results
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2014
Event Type  malfunction  
Event Description
The following was reported by the patient's nurse: the patient is uncooperative and tends to play with her lines, and the staff feels that the patient may have pulled the tubing apart.Estimated blood loss was 100mls.The staff has set up a new unit for the patient; however the patient refused to dialyze any further (which is not unusual for patient).No medical intervention was required.
 
Manufacturer Narrative
This mdr contains all info to date.A f/u report will be filed upon completion of the plant's investigation.
 
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Brand Name
CUSTOM COMBI SET
Manufacturer (Section D)
REYNOSA PLANT
reynosa, tamps
MX 
Manufacturer (Section G)
REYNOSA PLANT
parque ind. reynosa sur, brecha e-99
apartado postal #326
reynosa, tamps, cp 8878 0
MX   88780
Manufacturer Contact
tanya taft
920 winter street
waltham, MA 02451
7816999000
MDR Report Key3865399
MDR Text Key4506457
Report Number8030665-2014-00152
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 01/10/2014
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/10/2014
Initial Date FDA Received02/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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