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U.S. Department of Health and Human Services

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

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ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number UNKNOWN- FMC BLOODLINE
Device Problem Fluid/Blood Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 05/16/2018
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
It was reported that a patient did not connect the bloodline to the dialyzer properly therefore creating a blood leak.It is unknown how far long into treatment the blood leak occurred.The patient¿s estimated blood loss is unknown.Additional information received, stated that the leak was external and it was at the connection between the bloodline and the dialyzer.Additionally, the blood was visually observed on the floor.The patient ended up requiring blood transfusion (amount unknown).The patient has a dialysate flow rate (dfr) of 300 and blood flow rate (bfr) of 300.The complaint device is not available to be returned to the manufacturer fro physical evaluation.
 
Manufacturer Narrative
Clinical investigation: there is a temporal relationship between the patient blood loss and hemodialysis (hd) therapy on the 2008k@home machine, however, the patient reported that he did not properly connect the bloodline to the dialyzer which resulted in a blood leak directly causing the patient blood loss.There is no allegation that the 2008k@home machine malfunctioned or that there was any deficiency in performance.The cause of the blood loss is directly related to the improper connection by the patient the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Manufacturer Narrative
The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.A device history review was not performed since the lot number of the alleged device is unknown.
 
Event Description
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Brand Name
FMC BLOODLINE
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
MDR Report Key7596412
MDR Text Key110910335
Report Number8030665-2018-00898
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 company representative,consum
Type of Report Initial,Followup,Followup
Report Date 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNKNOWN- FMC BLOODLINE
Device Lot NumberUNKNWON
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Device Age MO
Initial Date Manufacturer Received 06/12/2018
Initial Date FDA Received06/13/2018
Supplement Dates Manufacturer Received06/14/2018
07/04/2018
Supplement Dates FDA Received06/15/2018
07/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FRESENIUS 2008K@ HOME MACHINE; FRESENIUS OPTIFLUX F250NRE DIALYZER; FRESENIUS 2008K@ HOME MACHINE; FRESENIUS OPTIFLUX F250NRE DIALYZER
Patient Outcome(s) Required Intervention;
Patient Age51 YR
Patient Weight87
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