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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 No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2018
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility reported that during a patient hemodialysis (hd) treatment the fresenius 2008k2 machine had an unstable transmembrane pressure (tmp).It was reported that the patient was moved to another machine to complete treatment with new supplies.It was also reported that there was blood loss experienced by the patient.However, patient¿s estimated blood loss was unknown.It is unknown if there was any patient adverse event or medical intervention required.Additional information was solicited; however to date none has been received.
 
Manufacturer Narrative
The sample was not returned to the manufacturer and the lot number was not provided.Since there is no information of product, lot number, patient¿s alternate identifier and clinic; is not possible to obtain any potential lot delivered to the patient in order to retrieve alternate samples from distribution center for evaluation.Lot trend evaluation was not performed since the product and lot number are unknown and there is not information to a possible lot number from product fmc bloodline.No device history review was performed since there is not information of any lot number.
 
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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 Key7575656
MDR Text Key110345242
Report Number8030665-2018-00870
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
Type of Report Initial,Followup
Report Date 08/03/2018
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 Catalogue NumberUNKNOWN- FMC BLOODLINE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Device Age MO
Initial Date Manufacturer Received 05/09/2018
Initial Date FDA Received06/06/2018
Supplement Dates Manufacturer Received07/27/2018
Supplement Dates FDA Received08/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FRESENIUS 2008K2 MACHINE
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