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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. HOME HEMO COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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ERIKA DE REYNOSA, S.A. DE C.V. HOME HEMO COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number 03-2962-3
Device Problem Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/13/2016
Event Type  malfunction  
Manufacturer Narrative
The reported complaint is not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lot passed all release criteria.Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.
 
Event Description
A patient reported observing air bubbles in the bloodline near the arterial chamber.The event occurred approximately 3 hours into the patient's home hemodialysis (hd) treatment.The patient ended treatment and started to do a manual return of his blood.The patient was able to return approximately 3/4 of the blood within the extracorporeal circuit.The patient's estimated blood loss (ebl) was noted as being approximately 1/4 of the blood that was left in the circuit.The patient indicated that no air was visible in the venous return line.The machine alarmed for air appropriately.No patient adverse effects were experienced and no medical intervention was required as a result of this event.No bloodline damage was visible.The complaint device is not available to be returned to the manufacturer for evaluation as it was discarded by the patient.
 
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Brand Name
HOME HEMO COMBI SET
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX  88780
Manufacturer (Section G)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX   88780
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key6084050
MDR Text Key59332622
Report Number8030665-2016-00558
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
PMA/PMN Number
K070049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 11/07/2016
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 Lay User/Patient
Device Expiration Date01/31/2019
Device Catalogue Number03-2962-3
Device Lot Number16AR01291
Other Device ID Number00840861100330
Was Device Available for Evaluation? No
Device AgeMO
Initial Date Manufacturer Received 10/13/2016
Initial Date FDA Received11/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FRESENIUS K@HOME HEMODIALYSIS MACHINE
Patient Age59 YR
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