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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. SECONDARY IV ADMINISTRATION SET

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B. BRAUN DOMINICAN REPUBLIC INC. SECONDARY IV ADMINISTRATION SET Back to Search Results
Catalog Number V1921
Device Problems Air Leak (1008); Compatibility Problem (2960)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2015
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b. Braun medical inc. (b)(4). One used secondary iv tubing set, without packaging, was received for evaluation. A phaseal spike adapter was connected between the secondary set and iv bag. In an attempt to replicate the reported event, the returned tubing set (with phaseal device still attached) was tested at 10 psi air pressure. Leakage was observed from the spike of the phaseal adapter. The phaseal adapter was then removed, and the tubing set was separately tested for leakage according to specification with acceptable results. There were no leakages noted from any location along the tubing set itself. The returned secondary set was then attached to a primary set, primed, and loaded into an infusomat space pump as per the instructions for use. The pump rate was set at 540 ml/hr and the set ran for approximately one hour. During this time, there were no air bubbles observed in any location of the tubing set and the pump did not alarm any errors. Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event. The phaseal adapter is not a b. Braun manufactured item. The returned secondary set met requirements according to specification. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number. Without the lot number, a thorough batch record review could not be performed. If additional pertinent information becomes available, a follow-up report will be filed.
 
Event Description
As reported by the user facility: reports during administration of cyclophosphamide (cytoxan), air seems to be getting introduced into the tubing system above the pump set. Clinicians have seen this occurring when using phaseal bag spike products. The drip chamber of the secondary set becomes empty even though there is still about 20 - 30 ml of solution left in the bag. The rate is set at 540 ml/hr and the roller clamp to the primary set is closed during administration. There is no trouble with the iv sets until used with a phaseal product.
 
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Brand NameSECONDARY IV ADMINISTRATION SET
Type of DeviceSECONDARY IV ADMINISTRATION SET
Manufacturer (Section D)
B. BRAUN DOMINICAN REPUBLIC INC.
las americas industrial park
km22 autopista las americas
santo domingo, dominican republic
DR
Manufacturer Contact
eric roden
las americas industrial park
km22 autopista las americas
santo domingo, dominican republic 
DR  
5491000
MDR Report Key5913991
MDR Text Key54279399
Report Number9614279-2016-00056
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790062
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/16/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberV1921
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2015
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 Initial

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