MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. INFUSOMAT® SPACE PUMP IV SET; SPACE PUMP IV SET WITH CARESITE VALVE

Catalog Number 363421

Device Problems Leak/Splash (1354); Chemical Spillage (2894)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample or lot number, a thorough sample analysis or batch record review could not be performed and no specific conclusions can be drawn.While no specific conclusions can be drawn, the reporting facility did indicate that the issue was resolved when hand tightening the asv connection.The asv valve contained on the reported set is a removable component.Per the instructions for use for the reported catalog number, it is indicated to "tighten asv and remove end cap." no adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by the user facility: reports leakage occurred at the connection to the anti-siphon valve (asv), causing a chemo spill on the patient's skin.The reporter stated this issue was resolved by hand tightening the asv connection.

• Brand Name: INFUSOMAT® SPACE PUMP IV SET
• Type of Device: SPACE PUMP IV SET WITH CARESITE VALVE
• 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 Key: 5608109
• MDR Text Key: 44459331
• Report Number: 9614279-2016-00016
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 363421
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2016
• 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 Number: 1